FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
6385–6408 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 18, 1992
ANGEION ENDOSCOPIC VALVE SEAL
K915719 · ODC
Angeion Corp.
Gastroenterology & Urology · 60d
Cleared Feb 14, 1992
MOSS - ANCHOR SET
K913701 · FPD
Moss Medical Products
Gastroenterology & Urology · 179d
Cleared Feb 12, 1992
GI BLEEDER/OD SET
K913476 · KNT
Icu Medical, Inc.
Gastroenterology & Urology · 191d
Cleared Feb 07, 1992
SUPERLOGGER
K912772 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 228d
Cleared Feb 07, 1992
AUTO-VAC BIOPSY NEEDLE
K912892 · KNW
Angiomed GmbH & Co. Medizintechnik KG
Gastroenterology & Urology · 221d
Cleared Feb 07, 1992
DOBBHOFF ANORECT BIOFEED SYST FIVE DIV FECAL CONST
K913736 · FAP
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 171d
Cleared Feb 07, 1992
LOPEZ VALVE TM II
K915171 · KNT
Icu Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 05, 1992
RIWOLITH 2280
K913487 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 183d
Cleared Feb 05, 1992
CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH)
K915246 · EXI
Coloplast A/S
Gastroenterology & Urology · 82d
Cleared Jan 31, 1992
HEART PACK III
K914933 · KOD
Westmark Hospital Supplies
Gastroenterology & Urology · 88d
Cleared Jan 30, 1992
NAUDE URETHRAL STENT
K912851 · KOD
Cook Urological, Inc.
Gastroenterology & Urology · 216d
Cleared Jan 30, 1992
E.R.C.P. CATHETER
K914495 · FGE
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 114d
Cleared Jan 30, 1992
URETEROSCOPE
K915458 · FGB
Psi Medical Products, Inc.
Gastroenterology & Urology · 57d
Cleared Jan 30, 1992
CHOLEDOCHOSCOPE
K915681 · FBN
Applied Laparoscopy
Gastroenterology & Urology · 42d
Cleared Jan 28, 1992
CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
K913986 · FGE
Medical Dynamics, Inc.
Gastroenterology & Urology · 145d
Cleared Jan 27, 1992
BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER
K913341 · EZC
C.R. Bard, Inc.
Gastroenterology & Urology · 185d
Cleared Jan 24, 1992
QUICVAGE
K914907 · KDH
Autovage
Gastroenterology & Urology · 84d
Cleared Jan 23, 1992
DANTEC UD 5500 MK2
K913169 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 190d
Cleared Jan 23, 1992
ECONOAID
K914557 · LKY
Gromedco
Gastroenterology & Urology · 100d
Cleared Jan 23, 1992
URIHESIVE STRIP
K915616 · EXI
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 38d
Cleared Jan 15, 1992
DOBBHOFF(R) SINGLE PASS PEG KIT
K913784 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 145d
Cleared Jan 13, 1992
OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES
K904940 · FJL
Olympus Corp.
Gastroenterology & Urology · 438d
Cleared Jan 13, 1992
SELECTRA AND TUBING SETS
K910173 · FKX
Medionics International , Ltd.
Gastroenterology & Urology · 363d
Cleared Jan 10, 1992
PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P
K914008 · FAJ
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 123d