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
7849–7872 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 02, 1986
MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA
K861046 · LNK
Sharplan Industries, Inc.
Gastroenterology & Urology · 45d
Cleared Apr 29, 1986
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER
K860362 · KNX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 89d
Cleared Apr 25, 1986
MONITRAL S
K861230 · FKP
Hospal Medical Corp.
Gastroenterology & Urology · 24d
Cleared Apr 24, 1986
MMG EXTERNAL FEMALE CATHETERS
K854821 · KNX
Medical Technologies of Georgia
Gastroenterology & Urology · 142d
Cleared Apr 23, 1986
URDYN 5000 (UROFLOWMETER)
K860368 · FFO
Dantec Electronics, Inc.
Gastroenterology & Urology · 79d
Cleared Apr 23, 1986
VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE
K860771 · GCQ
Van-Tec, Inc.
Gastroenterology & Urology · 51d
Cleared Apr 23, 1986
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA
K861174 · LFJ
Shiley, Inc.
Gastroenterology & Urology · 29d
Cleared Apr 23, 1986
GENTLE BACK, PLASTIC URINARY DRAINAGE BAG
K861192 · KNX
Advanced Clinical Products, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 23, 1986
UROTOPO CATHETER
K861200 · KOD
Houston Biomedical, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 17, 1986
PERITONE DISPOSAL SHEATH - RUBBER AND VINYL
K860552 · HIR
Laurie Ann Kaiser, Ph.D.
Gastroenterology & Urology · 62d
Cleared Apr 17, 1986
LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35
K860822 · FAJ
Cooper Lasersonics, Inc.
Gastroenterology & Urology · 44d
Cleared Apr 17, 1986
AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N
K861251 · KNX
American Medical Products, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 16, 1986
DURAHESIVE PROTECTIVE BARRIER WIPE
K855019 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 121d
Cleared Apr 08, 1986
SUPERCATH A.V. FISTULA
K854773 · FIE
Togo Medikit Co., Ltd.
Gastroenterology & Urology · 130d
Cleared Apr 08, 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855097 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 106d
Cleared Apr 08, 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855098 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 106d
Cleared Apr 08, 1986
MEDCOMP'S FEMORAL VEIN CATHETERS
K860810 · LFK
Medical Components, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1986
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K861181 · KOD
Beiersdorf, Inc.
Gastroenterology & Urology · 8d
Cleared Apr 07, 1986
HURWITZ DIALYSIS CATHETER
K860094 · LFJ
Gish Biomedical, Inc.
Gastroenterology & Urology · 87d
Cleared Apr 07, 1986
TELESCOPE PROTECTION TUBE
K860265 · KOD
R. J. Ltd., Ind.
Gastroenterology & Urology · 70d
Cleared Apr 07, 1986
HGM, INC. LASERCATH (STERILE)
K860357 · LNK
Hgm, Inc.
Gastroenterology & Urology · 67d
Cleared Apr 07, 1986
CHALLENGER HOT BIOPSY FORCEPS
K860366 · KNS
Microvasive
Gastroenterology & Urology · 63d
Cleared Apr 07, 1986
INFLATOR/DEFLATOR PISTON SYRINGE
K860589 · KNT
Microvasive
Gastroenterology & Urology · 47d
Cleared Apr 07, 1986
DRS-4 DIALYZER REPROCESSING SYSTEM
K860674 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 42d