Device, Cystometric, Hydraulic

FDA product code FEN · 36 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.1620
Review panel: GU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1991-02-19 – 2021-12-21

FEN 2021-12-21

CT3000Pro

Applicant Srs Medical

K number K212830

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FEN 2008-12-18

URONIRS, MODEL 2000

Applicant Urodynamix Technologies, Ltd.

K number K082701

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FEN 2008-03-05

LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY

Applicant Laborie Medical Technologies, Corp.

K number K073552

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FEN 2000-07-17

ACCUSET SENSOR, MODEL 2000

Applicant Pelvicare, Inc.

K number K001386

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FEN 2000-02-28

NEURO URODYNAMIC SUITE, MODEL 9032E0101

Applicant Medtronic Functional Diagnostics A/S

K number K992715

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FEN 1998-11-24

IN-PROBE II URODYNAMIC SYSTEM

Applicant Influence, Inc.

K number K983325

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FEN 1997-10-24

CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP

Applicant Circon Video

K number K970595

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FEN 1997-06-03

LUMAX CYSTOMETRY ADMINISTRATION TUBE SET

Applicant Medamicus, Inc.

K number K971911

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FEN 1997-03-21

ELLIPSE 4

Applicant Andromeda Medizinische Systeme GmbH

K number K964522

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FEN 1996-09-16

DANTEC DUET

Applicant Dantec Medical, Inc.

K number K960503

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FEN 1996-01-18

LUMAX(MODIFICATION)

Applicant Medamicus, Inc.

K number K953734

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FEN 1996-01-11

LUMAX (MODIFICATION)

Applicant Medamicus, Inc.

K number K954093

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FEN 1995-11-30

PVC ABDOMINAL/RECTAL PRESSURE CATHETER

Applicant Life-Tech Intl., Inc.

K number K954315

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FEN 1995-10-17

URODYNAMICS TUBING AND INFUSION SETS

Applicant Life-Tech Intl., Inc.

K number K954341

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FEN 1995-10-05

UROPUMP TUBE & DAMPING CHAMGER

Applicant Life-Tech Intl., Inc.

K number K953451

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FEN 1995-09-08

UROVISION JANUS

Applicant Life-Tech Intl., Inc.

K number K953353

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FEN 1995-07-06

PIPER, MODEL NUMBER UDS-PIPERB

Applicant Laborie Medical Technologies, Ltd.

K number K951805

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FEN 1995-06-15

RUSCH URODYNAMIC RECTAL BALLOON CATHETER

Applicant Rusch Intl.

K number K952573

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FEN 1995-06-13

RUSCH INTERNATIONAL URODYNAMIC CATHETERS

Applicant Rusch Intl.

K number K952029

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FEN 1995-05-11

FST FIBEROPTIC PRESSURE CONVERTER

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K945753

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FEN 1995-04-07

FST CATH-UD, CATHETER

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K950908

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FEN 1995-03-30

CART, MODE NUMBER UDS-CART

Applicant Laborie Medical Tech Corp.

K number K950016

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FEN 1995-02-07

OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM

Applicant Surgitek

K number K944391

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FEN 1994-07-12

INFUSION PUMP, MODEL NO. UDP-5

Applicant Laborie Medical Technologies, Ltd.

K number K942023

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FEN 1994-04-18

UROGRAM CYSTOMETROGRAM

Applicant Myo/Kinetic Systems, Inc.

K number K936041

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FEN 1994-03-30

TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS

Applicant Life-Tech Intl., Inc.

K number K940203

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FEN 1993-11-18

STAND ALONE CYSTOMETROGRAM

Applicant Medical Engineering Corp.

K number K934141

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FEN 1993-11-04

FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K930171

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FEN 1993-11-02

KENDALL URODYNAMIC CATHETERS

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K933399

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FEN 1993-10-08

SILICONE RECTAL BALLOON

Applicant Cook Urological, Inc.

K number K930135

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FEN 1993-09-21

BARD URODYNAMIC CATHETER

Applicant C.R. Bard, Inc.

K number K924714

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FEN 1993-07-20

FST COUNCIL TIP FOLEY CATHETER

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K922776

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FEN 1993-06-18

FST CATH UD-DUAL DUAL PRESSURE CATHETER

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K926088

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FEN 1991-10-09

FST CATH-UD CATHETER, MODIFICATION

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K913113

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FEN 1991-10-08

FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K913721

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FEN 1991-02-19

FST CATH-UD CATHETER

Applicant Fiberoptic Sensor Technlogies, Inc.

K number K905641

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