Spatula, Cervical, Cytological

FDA product code HHT · 72 cleared devices

Class 2 Obstetrics/Gynecology

Regulation: 21 CFR 884.4530
Review panel: OB
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-01-18 – 2019-04-25

HHT 2019-04-25

exCellerator Cervical Collection Device

Applicant Excell Company, LLC

K number K182049

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HHT 2017-01-13

Kolplast Cervical Sample Collection Kit

Applicant Kolplast CI SA

K number K153128

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HHT 2012-01-19

HISTOBRUSH

Applicant Puritan Medical Products Company, LLC

K number K111681

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HHT 2009-04-09

PAPCONE

Applicant Otto Bock Pur Life Science GmbH

K number K083012

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HHT 2008-12-05

BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY

Applicant Bio Nuclear Diagnostics, Inc.

K number K081522

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HHT 2008-01-30

SOFTPAP CERVICAL CELL COLLECTOR

Applicant Cytocore, Inc.

K number K072381

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HHT 2007-03-16

DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM

Applicant Diamics, Inc.

K number K062433

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HHT 2005-02-02

CERVEX-BRUSH COMBI

Applicant Rovers Medical Devices B.V.

K number K043369

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HHT 2004-11-08

SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107

Applicant Medical Action Industries, Inc.

K number K042527

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HHT 2004-10-18

DRG SOFTRELEASE

Applicant Doctor'S Research Group, Inc.

K number K041018

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HHT 2002-05-31

INPATH E2 COLLECTOR

Applicant Molecular Diagnostics

K number K013258

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HHT 2000-11-13

ROVERS SPATULA

Applicant Rovers Medical Devices B.V.

K number K002520

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HHT 2000-05-19

ROVERS ENDOCERVEX-BRUSH

Applicant Rovers Medical Devices B.V.

K number K001119

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HHT 1999-06-29

ORIBRUSH - WITH PROTECTIVE TIP - B001

Applicant Orifice Medical AB

K number K991595

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HHT 1999-06-29

ORIBRUSH - STANDARD - B002

Applicant Orifice Medical AB

K number K991593

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HHT 1999-03-15

HARWILL MEDICAL CERVITULA CERVICAL SPATULA

Applicant Harwill Medical (Pty) , Ltd.

K number K983202

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HHT 1998-12-11

SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT

Applicant Andwin Scientific

K number K983599

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HHT 1998-11-16

SAFETEX CERVICAL SCRAPER (PLASTIC)

Applicant Andwin Scientific

K number K983428

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HHT 1998-04-16

CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010

Applicant Canadian Medical Brush, Inc.

K number K980356

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HHT 1997-09-19

DIGENE CERVICAL BRUSH

Applicant Digene Corp.

K number K971586

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HHT 1997-07-24

CYTOLOGY BRUSH

Applicant Team Technologies, Inc.

K number K971849

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HHT 1997-04-09

PAP BRUSH

Applicant Young OU Brush Co.

K number K963801

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HHT 1996-10-11

EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER

Applicant North Eos Industries, Inc.

K number K963685

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HHT 1996-07-09

PURITAN FOAM TIP SWAB MODEL 2197

Applicant Hardwood Products Co., LP

K number K961934

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HHT 1996-03-14

DETECT CYTOLOGY BRUSH II

Applicant Cook Urological, Inc.

K number K960469

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HHT 1995-12-22

GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT

Applicant Gynetech, Inc.

K number K954562

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HHT 1995-07-25

AMSINO CERVICAL SCRAPER

Applicant Amsino Intl., Inc.

K number K950780

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HHT 1995-02-28

CERVEX-BRUSH PAP KIT

Applicant Rovers Diagnostic Devices

K number K941472

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HHT 1995-01-05

VIBA-BRUSH

Applicant Rovers B.V.

K number K933870

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HHT 1994-12-30

PELVIC EXAM TRAY

Applicant Medcare Custom Packaging, Inc.

K number K934732

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HHT 1994-12-08

CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY

Applicant Rovers Diagnostic Devices

K number K942843

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HHT 1994-05-24

CERVEX-BRUSH

Applicant Rovers B.V.

K number K930955

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HHT 1994-05-02

MICRO-PAP(TM) KIT

Applicant Micro-Pap Corp.

K number K912325

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HHT 1994-03-11

CYTOLOGY BRUSH

Applicant Bioteque America, Inc.

K number K933628

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HHT 1994-02-25

DETECT (TM) CYTOLOGY BRUSH

Applicant Cook Ob/Gyn

K number K933415

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HHT 1994-01-07

EXACT-TOUCH

Applicant Baal Assoc., Inc.

K number K915844

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HHT 1993-09-03

ACCELLON CERVICAL BIOSAMPLER

Applicant Medscand AB

K number K911432

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HHT 1993-07-16

CYTO PAK PAP SMEAR KIT

Applicant International Medical Equipment Brokers, Inc.

K number K923143

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HHT 1993-04-13

CELL COLLECTING BRUSH

Applicant Anderson Winn Paper Co.

K number K924908

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HHT 1991-05-21

CELL SWEEP

Applicant Reza S Mohajer, M.D. C/O Krass & Young

K number K911327

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HHT 1991-01-31

PC-BEADS POSTCOITAL TEST

Applicant Microscopy Research Innovations

K number K902995

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HHT 1990-09-10

CYTETTE(TM) CYTOLOGY BRUSH

Applicant Birchwood Laboratories, Inc.

K number K902591

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HHT 1990-09-10

CYTOSET(TM)

Applicant Birchwood Laboratories, Inc.

K number K902589

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HHT 1990-02-22

SPATULA FOR PAP SMEAR COLLECTION

Applicant Medical Device Inspection Co., Inc.

K number K893229

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HHT 1990-01-04

WALLACH CC/BRUSH

Applicant Wallach Surgical Devices, Inc.

K number K896065

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HHT 1989-12-11

PAP SMEAR TRAY

Applicant Intl. Cytobrush, Inc.

K number K895675

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HHT 1989-05-11

CERVEX-BRUSH

Applicant Unimar, Inc.

K number K890848

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HHT 1989-04-25

CYTOBRUSH

Applicant Laboratoire Ccd C/O Washington Regulatory Services

K number K890706

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HHT 1989-04-25

KOTEX SUPER MAXI PADS

Applicant Kimberly-Clark Corp.

K number K890013

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HHT 1989-03-22

ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG

Applicant Zinnanti Surgical Instruments, Inc.

K number K891032

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HHT 1989-03-16

CYTEX ONE AND CYTEX TWO

Applicant Anderson Winn Paper Co.

K number K890283

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HHT 1989-03-09

ROCKET ENDOCERVICAL BRUSH

Applicant A & A Medical, Inc.

K number K885274

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HHT 1989-02-09

CERVICAL BRUSH

Applicant Statlab Medical Products, Inc.

K number K884873

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HHT 1988-10-07

ROCKET CERVICAL SPATULA

Applicant A & A Medical, Inc.

K number K884042

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HHT 1988-07-25

ENDO C BRUSH

Applicant Milex Products, Inc.

K number K882628

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HHT 1988-07-19

C-E BRUSH

Applicant Surgipath Medical Industries, Inc.

K number K881921

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HHT 1988-01-27

ORTHO* SPECIMEN COLLECTION CYTOLOGY BRUSH

Applicant Ortho Diagnostic Systems, Inc.

K number K875162

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HHT 1988-01-07

HISTOBRUSH

Applicant Spectrum Co.

K number K874604

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HHT 1987-06-26

ORTHO* SPECIMEN COLLECTION CYTOBRUSH

Applicant Ortho Diagnostic Systems, Inc.

K number K871552

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HHT 1987-05-18

CYCLO-BRUSH

Applicant Medline Industries, Inc.

K number K870782

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HHT 1987-02-25

PAP-PAK CYTOBRUSH KIT

Applicant Medical Packaging Corp.

K number K870398

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HHT 1987-01-09

CYTOLOGY BRUSHES

Applicant Medical Packaging Corp.

K number K864323

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HHT 1986-08-19

CERVICAL SCRAPERS

Applicant Surgipath Medical Industries, Inc.

K number K863145

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HHT 1986-07-07

CHLAMYDIA KIT, STD KIT

Applicant Intl. Cytobrush, Inc.

K number K862322

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HHT 1986-06-26

PAP SMEAR KIT

Applicant Quali-Med, Inc.

K number K862242

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HHT 1986-05-02

PAP SMEAR KIT

Applicant Intl. Cytobrush, Inc.

K number K861389

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HHT 1985-07-05

CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA

Applicant Tridak Division of Indicon, Inc.

K number K851934

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HHT 1985-03-22

SURGI-PAP KIT

Applicant Surgipath Medical Industries, Inc.

K number K850676

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HHT 1984-02-10

PAP SMEAR BRUSH

Applicant Donald G. Zeller

K number K832986

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HHT 1981-06-23

CERVICAL SPATULA

Applicant Procedure Products, Inc.

K number K811548

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HHT 1980-10-31

SPATULA, CERVICAL CYTOLOGICAL CYTOLOGY

Applicant Dyn-A-Med Products

K number K802139

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HHT 1977-01-18

CERVICAL-VAGINAL SPATULA

Applicant Law Offices of Natter & Natter

K number K761348

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