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
5089–5112 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 19, 1997
COMEG ENDOSCOPY GRASPING FORCEPS
K970489 · FFL
Comeg Endoscopy
Gastroenterology & Urology · 37d
Cleared Mar 18, 1997
KENDALL DUAL LUMEN CATHETER
K963446 · MPB
Kendall Healthcare Products Co....
Gastroenterology & Urology · 196d
Cleared Mar 18, 1997
AMSINO URINARY DRAINAGE BAG
K964745 · KNX
Amsino Intl., Inc.
Gastroenterology & Urology · 112d
Cleared Mar 18, 1997
COMPAT GASTROSTOMY/JEJUNOSTOMY FEEDING TUBE KIT(088000)
K965087 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 89d
Cleared Mar 14, 1997
FLEXIFLO FLOCATOR SMALL BOWEL FEEDING SYSTEM
K950017 · KNT
Ross Products
Gastroenterology & Urology · 801d
Cleared Mar 13, 1997
MANAN D BAG
K961986 · EXF
Manan Medical Products, Inc.
Gastroenterology & Urology · 296d
Cleared Mar 13, 1997
PERSONAL CATHETER
K970704 · GBM
Rochester Medical Corp.
Gastroenterology & Urology · 15d
Cleared Mar 12, 1997
INTEGRATED VISUALIZATION SYSTEM
K970598 · FCW
Urohealth, Inc.
Gastroenterology & Urology · 22d
Cleared Mar 11, 1997
SMARTGUIDE
K963894 · FCG
Ferguson Medical
Gastroenterology & Urology · 165d
Cleared Mar 11, 1997
GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS
K970372 · FDF
Precision Endoscopy of America, Inc.
Gastroenterology & Urology · 39d
Cleared Mar 11, 1997
KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE
K970427 · FGB
Karl Storz Endoscopy
Gastroenterology & Urology · 35d
Cleared Mar 04, 1997
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS
K954676 · KOC
Nissho Corp.
Gastroenterology & Urology · 511d
Cleared Mar 04, 1997
FLEXILOG 3000
K964589 · KLA
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 109d
Cleared Mar 04, 1997
PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
K965176 · OCZ
Pilling Weck Group
Gastroenterology & Urology · 70d
Cleared Mar 04, 1997
IMAGER TORQUE CATHETER
K965229 · KOD
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Feb 26, 1997
BARD DIRECTOR GUIDEWIRE (000560)
K964780 · OCY
C.R. Bard, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 25, 1997
ENDOCARE MONOPOLAR ELECTRODE
K965118 · FAS
Endocare, Inc.
Gastroenterology & Urology · 67d
Cleared Feb 25, 1997
HOLLISTER RETRACTED PENIS POUCH
K970443 · EXI
Hollister, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 21, 1997
TUM-E-VAC
K962850 · KDH
Ethox Corp.
Gastroenterology & Urology · 214d
Cleared Feb 20, 1997
FLEXIBLE CYSTOSCOPE
K964037 · FAJ
Applied Fiberoptics, Inc.
Gastroenterology & Urology · 135d
Cleared Feb 19, 1997
BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
K970110 · ODC
Bard Medical Div.
Gastroenterology & Urology · 37d
Cleared Feb 14, 1997
FLEXFINDER GUIDEWIRE (REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS...
K964955 · OCY
Flexmedics
Gastroenterology & Urology · 65d
Cleared Feb 13, 1997
EMS SWISS LITHOCLAST LITHOTRIPTER
K963285 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 176d
Cleared Feb 13, 1997
SPEEDBAND MULTIPLE BAND LIGATOR
K964079 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 125d