Catheter, Suprapubic (And Accessories)

FDA product code KOB · 31 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5090
Review panel: GU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-07-17 – 2024-11-01

KOB 2024-11-01

AMT Low-Profile Suprapubic Catheter & Drainage Set

Applicant Applied Medical Technology, Inc.

K number K240514

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KOB 2019-01-18

Cook Cystostomy Catheter Set

Applicant Cook Incorporated

K number K181097

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KOB 2018-12-26

One-Step Suprapubic Introducer

Applicant Cook Incorporated

K number K182709

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KOB 2018-10-30

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set

Applicant Cook Incorporated

K number K182066

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KOB 2012-10-26

SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM

Applicant Swan Valley Medical, Incorporated

K number K120127

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KOB 2002-03-04

ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890

Applicant Fortune Medical Instrument Corp.

K number K014002

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KOB 2001-09-19

LOWSLEY SUPRAPUBIC TRACTOR

Applicant Circon Video

K number K012153

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KOB 1997-04-23

KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET

Applicant The Kendal Co.

K number K970969

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KOB 1997-02-07

RUSCH SUPRAPUBIC TRAY

Applicant Rusch, Inc.

K number K970021

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KOB 1995-08-28

MOSS(R) STEEL BREAKAWAY(R) INTRODUCER

Applicant Harry A. Schlakman

K number K945480

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KOB 1995-08-18

LINDNER/GOLOMB SP INTRODUCING SOUND

Applicant Cook Urological, Inc.

K number K953024

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KOB 1995-07-25

RUSCH SUPRAFLEX SUPRAPUBIC CYSTOSTOMY CATHETER KIT, STERILE

Applicant Rusch, Inc.

K number K952187

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KOB 1992-03-26

DENTOLOCK

Applicant Dentmed , Ltd.

K number K921071

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KOB 1991-11-22

SUPRAPUBIC FLOW CONTROLLER

Applicant Olympus Corp.

K number K904798

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KOB 1991-02-01

SEXTON CYSTOTOMY URINE PUMP (SCUP2)

Applicant Phoenix Bioengineering, Inc.

K number K904434

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KOB 1990-06-06

SUPER STRENGTH DENTURE ADHESIVE CREAM

Applicant Teledyne Getz

K number K901938

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KOB 1990-05-04

MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER

Applicant Bivona Medical Technologies

K number K901603

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KOB 1988-10-25

ADD-A-CATH

Applicant Femcare , Ltd.

K number K884061

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KOB 1988-06-03

SPEC 5* SUPRAPUBIC CATHETER

Applicant Porges Corp.

K number K881097

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KOB 1988-01-27

URETHRAL DILATOR ENDOSCOPE

Applicant Advanced Surgical Intervention, Inc.

K number K874530

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KOB 1987-03-10

VAN-TEC C-FLEX SUPRAPUBIC BALLOON CATHETER SET

Applicant Van-Tec, Inc.

K number K870556

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KOB 1987-03-10

VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET

Applicant Van-Tec, Inc.

K number K870555

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KOB 1986-10-24

VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS

Applicant Angiomed U.S., Inc.

K number K863386

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KOB 1986-10-24

(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET

Applicant Cook Urological, Inc.

K number K863120

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KOB 1985-08-08

PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET

Applicant Cook Ob/Gyn

K number K852287

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KOB 1985-08-07

SIMPLASTIC SUPRA PUBIC CATHETER

Applicant Franklin Medical USA, Inc.

K number K852200

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KOB 1984-10-04

SEXTON CYSTOTOMY URINE PUMP

Applicant Holter-Hausner Intl.

K number K843158

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KOB 1981-12-31

CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET

Applicant Burron Medical Products, Inc.

K number K813084

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KOB 1981-03-20

VANCE PERCUTANEOUS MALECOT NEPHROSTOMY

Applicant Vance Products, Inc.

K number K810368

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KOB 1980-04-08

SUPRAPUBIC TROCAR

Applicant G.D. Searle and Co.

K number K800607

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KOB 1978-07-17

PERCUTANEOUS SURAPUBIC CATHETER

Applicant Vance Products, Inc.

K number K780765

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