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
4609–4632 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 26, 1999
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
K990687 · PKL
Olympus Optical, Co.
Gastroenterology & Urology · 25d
Cleared Mar 25, 1999
BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND...
K990072 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 73d
Cleared Mar 25, 1999
WILSON-COOK BIPOLAR PROBE
K990145 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 25, 1999
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
K990456 · KPI
Hollister, Inc.
Gastroenterology & Urology · 41d
Cleared Mar 22, 1999
KSEA ENDOSCOPE HOLDER
K990334 · OCV
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 47d
Cleared Mar 22, 1999
MOSS GASTROSTOMY TUBE
K990389 · KNT
Moss Tubes, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 18, 1999
GILTECH PLUS CONNECTING TUBE SET
K983624 · KDH
Giltech Plus, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 17, 1999
MODIFICATION OF MOSS P.E.G. TRAY
K984628 · KNT
Moss Tubes, Inc.
Gastroenterology & Urology · 77d
Cleared Mar 15, 1999
FLEXFINDER GUIDE WIRE(REGULAR SHAFT/STIFF SHAFT) MARKED INK BANDS, FLEXFINDER...
K990765 · OCY
Flexmedics
Gastroenterology & Urology · 7d
Cleared Mar 08, 1999
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · FIP
Minntech Corp.
Gastroenterology & Urology · 181d
Cleared Mar 05, 1999
RESTORE (AKA RE/STOR)
K983164 · MNG
Nebl, Inc.
Gastroenterology & Urology · 176d
Cleared Mar 05, 1999
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC...
K984607 · FBP
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 67d
Cleared Mar 03, 1999
GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
K983075 · FGE
Guidant Corp.
Gastroenterology & Urology · 182d
Cleared Mar 02, 1999
MOSS TUBES, INC. NASAL TUBE - MARK IV
K984629 · BSS
Moss Tubes, Inc.
Gastroenterology & Urology · 62d
Cleared Mar 01, 1999
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
K983476 · KNT
Navion Biomedical Corp.
Gastroenterology & Urology · 150d
Cleared Feb 26, 1999
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
K981125 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 336d
Cleared Feb 24, 1999
HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100...
K980386 · KDI
Gambro Healthcare
Gastroenterology & Urology · 387d
Cleared Feb 24, 1999
MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE
K984310 · KNT
Moss Tubes, Inc.
Gastroenterology & Urology · 84d
Cleared Feb 24, 1999
ERCO-VAC -C
K990006 · LKY
Ercons, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 24, 1999
ERCO-RIBBON -C
K990008 · LKY
Ercons, Inc.
Gastroenterology & Urology · 51d
Cleared Feb 16, 1999
BARDEX LUBRI-SIL I.C. FOLEY CATHETER
K984136 · MJC
Bard Medical Div.
Gastroenterology & Urology · 90d
Cleared Feb 12, 1999
MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY
K982333 · MSD
Cook, Inc.
Gastroenterology & Urology · 225d
Cleared Feb 12, 1999
SELF CATH SET/SAFETY CATH
K983010 · FCM
Rusch Intl.
Gastroenterology & Urology · 168d
Cleared Feb 12, 1999
WILSON-COOK PANCREATIC WEDGE STENT
K990130 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 29d