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
4537–4560 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 30, 1999
CRIT-LINE MONITOR III (CLM III)
K992227 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 28d
Cleared Jul 29, 1999
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
K991512 · FJI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Jul 29, 1999
MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
K991533 · FGE
Peripheral Ave
Gastroenterology & Urology · 87d
Cleared Jul 27, 1999
SWISS LITHOCLAST MULTIPURPOSE PROBE
K992251 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 21d
Cleared Jul 26, 1999
COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
K991668 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 73d
Cleared Jul 15, 1999
ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
K991389 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 85d
Cleared Jul 14, 1999
ELECTRO MECHANICAL LITHOTRIPTOR
K990341 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 161d
Cleared Jul 14, 1999
SMITH & NEPHEW SUTURE LOK
K991500 · OCW
Smith & Nephew Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 12, 1999
MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY
K982326 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 375d
Cleared Jul 07, 1999
VISER PENILE TUMESCENCE MONITOR
K991479 · LIL
Laborie Medical Tech Corp.
Gastroenterology & Urology · 70d
Cleared Jul 06, 1999
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323 · FFS
Smith & Nephew, Inc.
Gastroenterology & Urology · 78d
Cleared Jul 02, 1999
DD URETERAL STENT, INTEGRAL STENT
K982974 · FAD
Rusch Intl.
Gastroenterology & Urology · 311d
Cleared Jun 29, 1999
GYRUS ENDOUROLOGY SYSTEM
K990628 · KNS
Gyrus Medical , Ltd.
Gastroenterology & Urology · 124d
Cleared Jun 29, 1999
COAGULOOP
K991314 · FAS
American Medical Systems, Inc.
Gastroenterology & Urology · 74d
Cleared Jun 25, 1999
ASH ADVANTAGE PERITONEAL CATHETER
K991042 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 25, 1999
DAUM MRI/CONVENTIONAL BIOPSY KIT
K991366 · KNW
Daum GmbH
Gastroenterology & Urology · 66d
Cleared Jun 25, 1999
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
K991793 · FGE
AngioDynamics, Inc.
Gastroenterology & Urology · 30d
Cleared Jun 22, 1999
IMPACT BALLOON DILATION CATHETER
K983373 · KNQ
B. Braun/Mcgaw
Gastroenterology & Urology · 271d
Cleared Jun 22, 1999
VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO,...
K991005 · LLB
Dayspring Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 22, 1999
WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM
K991056 · MQR
Boston Scientific Corp
Gastroenterology & Urology · 84d
Cleared Jun 21, 1999
C-FLEX URETERAL STENTS
K991219 · FAD
Applied Medical Resources
Gastroenterology & Urology · 70d
Cleared Jun 18, 1999
RENAL LINK
K990953 · KPF
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Jun 18, 1999
GENYX MEDICAL INJECTION NEEDLE
K990996 · FBK
Genyx Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 11, 1999
COOPERSURGICAL INFRARED COAGULATOR
K990852 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 88d