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
4201–4224 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 29, 2001
REDTECH GIPC 2000
K004040 · FFX
Red-Tech, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 28, 2001
KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER
K002901 · MSD
The Kendall Company
Gastroenterology & Urology · 191d
Cleared Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000...
K010567 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 174d
Cleared Mar 27, 2001
ARTHROCARE UROLOGY ELECTROSURGERY SYSTEM
K010568 · KNS
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · ODC
Boston Scientific Corp
Gastroenterology & Urology · 26d
Cleared Mar 22, 2001
MEDICA HP 300 HEMOFILTRATION PUMP, MODEL 300
K000724 · KDI
Medica S.R.L.
Gastroenterology & Urology · 381d
Cleared Mar 22, 2001
K.E.A.T.
K002154 · KPI
Emd Electronic Medical Devices, Corp.
Gastroenterology & Urology · 248d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 92d
Cleared Mar 22, 2001
DAUM DOUBLE-SHOOT BISOPSY GUN
K010037 · KNW
Daum GmbH
Gastroenterology & Urology · 77d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445 · FGE
Cordis Corp.
Gastroenterology & Urology · 30d
Cleared Mar 13, 2001
ASPIRE COVERED STENT AND DELIVERY CATHETER
K003173 · ESW
Vascular Architects, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 08, 2001
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881 · MSB
Vitrolife Sweden AB
Gastroenterology & Urology · 353d
Cleared Mar 07, 2001
ENDOCARE PERCUTANEOUS ACCESS SET
K010339 · KOD
Endocare, Inc.
Gastroenterology & Urology · 30d
Cleared Mar 05, 2001
MENTOR SELF-CATH PLUS
K003784 · EZL
Mentor Corp.
Gastroenterology & Urology · 88d
Cleared Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · MND
Olympus America, Inc.
Gastroenterology & Urology · 264d
Cleared Feb 27, 2001
PARE ENDOSCOPIC SUTURING SYSTEM
K003102 · OCW
Pare Surgical, Inc.
Gastroenterology & Urology · 146d
Cleared Feb 22, 2001
URETEROSCOPES
K003806 · FGB
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 22, 2001
CYSTOSCOPES
K003807 · FAJ
Global Endoscopy, Inc.
Gastroenterology & Urology · 76d
Cleared Feb 16, 2001
COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX
K001916 · KNT
Novartis Nutrition Corp.
Gastroenterology & Urology · 238d
Cleared Feb 16, 2001
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K002045 · FIP
Total Water Treatment Systems, Inc.
Gastroenterology & Urology · 226d
Cleared Feb 16, 2001
VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
K002650 · FGE
Bentec Medical, Inc.
Gastroenterology & Urology · 175d
Not Cleared Feb 16, 2001
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
DEN000008 · NDS
Life Technologies, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 208d