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
9001–9024 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 12, 1982
URIFIX
K813537 · KNX
Isramed, Inc.
Gastroenterology & Urology · 25d
Cleared Jan 07, 1982
THE CHICAGO GULLET
K813132 · KNT
Universal Prosthetics, Inc.
Gastroenterology & Urology · 63d
Cleared Jan 07, 1982
ARGYLE PEDIATRIC URINE COLLECTOR
K813479 · KNX
Sherwood Medical Co.
Gastroenterology & Urology · 37d
Cleared Jan 07, 1982
ACESSORY TO MODIFIED FREEDING JEJUNOSTO
K813504 · KOA
Midwest Metabolic Support Group
Gastroenterology & Urology · 23d
Cleared Jan 05, 1982
TM-CAPD
K812615 · KPP
Tri-Med, Inc.
Gastroenterology & Urology · 112d
Cleared Dec 31, 1981
UREOFIX 500 URINE MEASURING SYSTEM
K813082 · FFG
Burron Medical Products, Inc.
Gastroenterology & Urology · 59d
Cleared Dec 31, 1981
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
K813084 · KOB
Burron Medical Products, Inc.
Gastroenterology & Urology · 59d
Cleared Dec 31, 1981
SHUNT ADAPTER
K813428 · FKN
Quinton, Inc.
Gastroenterology & Urology · 23d
Cleared Dec 31, 1981
CATHETER BUBBLE STAND
K813487 · FKX
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Dec 31, 1981
CATHETER REGULAR
K813488 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Dec 31, 1981
WATERS ILEAL RESERVOIR CATHETER
K813494 · KPH
Waters Instruments, Inc.
Gastroenterology & Urology · 17d
Cleared Dec 18, 1981
VPI URETERAL DILATATION BALLON CATHETER
K813278 · EZN
Vance Products, Inc.
Gastroenterology & Urology · 25d
Cleared Dec 18, 1981
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336 · FKO
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 24d
Cleared Dec 14, 1981
FECAL INCONTINENCE COLLATOR
K813270 · EXB
Hollister, Inc.
Gastroenterology & Urology · 24d
Cleared Dec 14, 1981
BRISTOL BALLON INTRODUCER, MANDRIL SET
K813332 · NWU
Inmed Corp.
Gastroenterology & Urology · 20d
Cleared Dec 08, 1981
D-3260 SORBENT CARTRIDGE
K812869 · FKT
Organon Teknika Corp.
Gastroenterology & Urology · 55d
Cleared Dec 03, 1981
MICROCOIL 80 DIALYZER
K812811 · FHS
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Dec 03, 1981
CELESTIN PULSION ESOPHOGEAL PROSTHESIS
K813169 · KNT
Inmed Corp.
Gastroenterology & Urology · 21d
Cleared Dec 03, 1981
TWO PIECE OSTOMY SYSTEM
K813269 · EXB
Hollister, Inc.
Gastroenterology & Urology · 13d
Cleared Nov 30, 1981
HEMASITE VASCULAR ACCESS SHUNT HM-1000
K813237 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Nov 20, 1981
HEPAFIX BIOPSY NEEDLE SET
K813085 · KNW
Burron Medical Products, Inc.
Gastroenterology & Urology · 18d
Cleared Nov 17, 1981
PENTAX FLEXIBLE DRIODENOFIBERSCOPE
K812810 · FAK
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 42d
Cleared Nov 17, 1981
ROBINSON CATHETERS NON-STERILE
K812887 · KOD
Abco Dealers, Inc.
Gastroenterology & Urology · 34d
Cleared Nov 17, 1981
GUIDE WIRE
K813026 · OCY
Inmed Corp.
Gastroenterology & Urology · 20d