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
5257–5280 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 25, 1996
ENDOPATH ETS LINEAR/ETS-FLEX ARTICULATING LINEAR ENDOSCOPIC CUTTER
K961390 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 76d
Cleared Jun 24, 1996
ES-3840, VIDEO SIGMOIDOSCOPE
K961567 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 62d
Cleared Jun 24, 1996
KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
K961570 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 62d
Cleared Jun 21, 1996
KNOW-RECIRC
K953551 · MQS
H&H Control Systems
Gastroenterology & Urology · 329d
Cleared Jun 21, 1996
URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY
K962073 · FCM
Continental Medical Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared Jun 19, 1996
EC-384OTL, VIDEO COLONSCOPE
K961563 · FDF
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 57d
Cleared Jun 14, 1996
ATI PLASMA PUMP (PP-04)
K961137 · FIR
Apheresis Technologies, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 13, 1996
PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM
K955423 · FKP
Fresenius USA, Inc.
Gastroenterology & Urology · 198d
Cleared Jun 11, 1996
BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC
K961040 · FJI
Dayspring Medical, Inc.
Gastroenterology & Urology · 89d
Cleared Jun 11, 1996
ESOPHAGEAL MANOMETRY ANALYSIS MODULE
K961070 · KLA
Synectics Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 11, 1996
AQ HYDROPHILIC UROLOGICAL CATHETERS
K962004 · EYB
Cook Urological, Inc.
Gastroenterology & Urology · 20d
Cleared Jun 10, 1996
LESE STENTS SETS
K952513 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 377d
Cleared Jun 10, 1996
BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL
K961026 · FJI
Dayspring Medical, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 06, 1996
BIOVIEW MODEL S960000
K961056 · KLA
Sandhill Scientific, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 05, 1996
U.S. ENDOSCOPY GROUP, INC. BALLOON REPLACEMENT GASTROSTOMY TUBE
K955181 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 205d
Cleared Jun 04, 1996
HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
K953681 · LKN
Haemonetics Corp.
Gastroenterology & Urology · 302d
Cleared Jun 04, 1996
7100 SWALLOWING WORKSTATION
K954798 · KLA
Kay Elemetrics Corp.
Gastroenterology & Urology · 230d
Cleared Jun 04, 1996
NIPRO ARTERIAL VENOUS FISTULA NEEDLE
K955182 · FIE
Nissho Corp.
Gastroenterology & Urology · 204d
Cleared May 28, 1996
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
K945559 · FIP
Mar Cor Services, Inc.
Gastroenterology & Urology · 565d
Cleared May 28, 1996
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
K961069 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 71d
Cleared May 28, 1996
BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE...
K961248 · FFL
C.R. Bard, Inc.
Gastroenterology & Urology · 57d
Cleared May 28, 1996
AQ HYDROPHILIC STENT
K961446 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 42d
Cleared May 23, 1996
MANAN INTRODUCER SHEALTH/NEEDLE
K961216 · FGE
Manan Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared May 21, 1996
U.S. ENDOSCOPY PULL PEG KIT & U.S. ENDOSCOPY GUIDEWIRE PEG KIT
K955248 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 188d