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
5209–5232 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 04, 1996
MICROVASIVE BALLOON GASTROSTOMY TUBE KIT
K962375 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 76d
Cleared Sep 04, 1996
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
K962595 · FFS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 64d
Cleared Aug 30, 1996
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
K961697 · EZL
Medical Device Intl., Inc.
Gastroenterology & Urology · 120d
Cleared Aug 29, 1996
CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
K935512 · KNT
Corpak Co.
Gastroenterology & Urology · 1017d
Cleared Aug 29, 1996
KSEA VAPORIZATION ELECTRODES
K961702 · FAS
Karl Storz Endoskop GmbH
Gastroenterology & Urology · 119d
Cleared Aug 29, 1996
LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
K962259 · KPL
Tiller Mind Body, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 28, 1996
REDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE...
K954623 · FKT
Gambro Healthcare
Gastroenterology & Urology · 328d
Cleared Aug 27, 1996
RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER
K962472 · FAP
Rusch Intl.
Gastroenterology & Urology · 63d
Cleared Aug 21, 1996
DIALYSIS MIXING & HOLDING TANK
K961416 · FIN
Dial Medical Supply
Gastroenterology & Urology · 131d
Cleared Aug 14, 1996
COBE CENTRYSYSTEM 600 HG HEMODIALYZERS
K960474 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 194d
Cleared Aug 14, 1996
NHMC IRRIGATION TRAY
K962670 · LJH
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 36d
Cleared Aug 09, 1996
INCARE PELVIC FLOOR THERAPY SYSTEM WITH DESKTOP COMPUTER
K961872 · KPI
Hollister, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 08, 1996
ALTRATOUCH 1000 HEMODIALYSIS DELIVERY SYSTEM
K954987 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 282d
Cleared Aug 08, 1996
PAPILLOTOME
K962346 · KNS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 51d
Cleared Aug 06, 1996
ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
K961825 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 88d
Cleared Aug 05, 1996
ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND...
K960574 · FHO
Sherwood Medical Co.
Gastroenterology & Urology · 175d
Cleared Aug 01, 1996
CATH CADDIE
K961884 · KNT
Mark-Clark
Gastroenterology & Urology · 78d
Cleared Aug 01, 1996
UROSURGE ACUTRAINER
K962770 · KPN
Princeton Regulatory Assoc.
Gastroenterology & Urology · 16d
Cleared Jul 31, 1996
PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955762 · KPF
Fresenius USA, Inc.
Gastroenterology & Urology · 226d
Cleared Jul 31, 1996
SNARE
K960230 · FDI
Lighthouse Medical, Inc.
Gastroenterology & Urology · 196d
Cleared Jul 31, 1996
SPHINCTEROTOME
K960231 · KNS
Lighthouse Medical, Inc.
Gastroenterology & Urology · 196d
Cleared Jul 31, 1996
BALLON DILATATION CATHETER
K961438 · KNQ
Boston Scientific Corp
Gastroenterology & Urology · 107d
Cleared Jul 31, 1996
P1R PLASMA TREATMENT SET FOR USE IN PLASMAPHERESIS WITH THE FRESENIUS AS104...
K961706 · LKN
Fresenius USA, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 31, 1996
OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY)
K962387 · FFL
Olympus America, Inc.
Gastroenterology & Urology · 41d