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
8449–8472 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 05, 1984
USCI ENDOPROSTHESIS
K834574 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 05, 1984
IRRIGATION SYSTEM
K840268 · EXD
Coloplast A/S
Gastroenterology & Urology · 73d
Cleared Apr 04, 1984
OP-CON SURG. INSTRUMENT #3
K834171 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 135d
Cleared Apr 04, 1984
ENTERNAL Y EXTENSION SET RECORDER
K840656 · KNT
Corpak Medsystems
Gastroenterology & Urology · 49d
Cleared Apr 04, 1984
DIETO CONTAINER FOR ENTERNAL NUTRIT
K840916 · KNT
Gil-Med Industries C/O Kegan & Kegan,...
Gastroenterology & Urology · 35d
Cleared Apr 04, 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · EXB
Howmedica Corp.
Gastroenterology & Urology · 23d
Cleared Apr 03, 1984
MID-STREAM URINE COLLECTION SETS
K840709
Concord Laboratories, Inc.
Gastroenterology & Urology · 46d
Cleared Apr 02, 1984
FIBERLAS 100 MEDICAL SYSTEM
K833499 · LNK
Fiberlase U.S.A.
Gastroenterology & Urology · 180d
Cleared Apr 02, 1984
SURGITEK ALL SILICONE INFECTION DOUBJ
K833782 · FAD
Surgitek
Gastroenterology & Urology · 157d
Cleared Apr 02, 1984
FLEXI-FLATE PENILE IMPLANT
K834347 · FAE
Surgitek
Gastroenterology & Urology · 111d
Cleared Apr 02, 1984
PARALLEL DUAL LUMEN SUBCLAVIAN CANNULA
K834358 · FIQ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 111d
Cleared Apr 02, 1984
MC 2002 OSTOMY POUCHES & SKIN FLANGES
K840265 · EXB
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
FILTRODER FILTERS
K840267 · EXB
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
MC 2000 OSTOMY POUCHES
K840269 · EXB
Coloplast A/S
Gastroenterology & Urology · 70d
Cleared Apr 02, 1984
BIOSPAL 3000S
K840811 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 2400S
K840812 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 41d
Cleared Apr 02, 1984
BIOSPAL 1200S
K840813 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 45d
Cleared Apr 02, 1984
HOSPAL MODEL H1210
K840814 · FKQ
Hospal Medical Corp.
Gastroenterology & Urology · 45d
Cleared Mar 30, 1984
NIGHT TRAINER
K834311 · KPN
Maddak, Inc.
Gastroenterology & Urology · 126d
Cleared Mar 23, 1984
ECHO MM1000
K834447 · LIF
Mesa Medical, Inc.
Gastroenterology & Urology · 98d
Cleared Mar 23, 1984
AMICON DIAFILTER 40. HEMOFILTER
K840449 · KDI
Medical Device Consultants, Inc.
Gastroenterology & Urology · 51d
Cleared Mar 23, 1984
BLOOD CONCENTRATOR 140
K840543 · KDI
Gambro, Inc.
Gastroenterology & Urology · 44d
Cleared Mar 23, 1984
POLYP-SAVER SLEVE
K840800 · OCZ
Jayco Pharmaceuticals
Gastroenterology & Urology · 29d
Cleared Mar 22, 1984
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19
K834191 · KOA
Imm Enterprises , Ltd.
Gastroenterology & Urology · 122d