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
4009–4032 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 25, 2002
KPS-I, THE KIDNEY PERFUSION SOLUTION
K013575 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 88d
Cleared Jan 18, 2002
BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
K010549 · FGE
Medi-Globe Corp.
Gastroenterology & Urology · 326d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER
K012328 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 179d
Cleared Jan 18, 2002
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION
K012547 · KPO
Di-Chem, Inc.
Gastroenterology & Urology · 164d
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · FGE
Guidant Corp.
Gastroenterology & Urology · 29d
Cleared Jan 17, 2002
MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY...
K014136 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 31d
Cleared Jan 15, 2002
PRISMASATE
K013448 · KPO
Gambro Renal Products
Gastroenterology & Urology · 90d
Cleared Jan 14, 2002
INCARE ADVANCE
K013483 · KOD
Hollister, Inc.
Gastroenterology & Urology · 87d
Cleared Jan 14, 2002
MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
K014205 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 24d
Cleared Jan 11, 2002
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · FPD
Vygon Corp.
Gastroenterology & Urology · 445d
Cleared Jan 08, 2002
SURX RADIOFREQUENCY ELECTROSURGICAL GENERATOR SYSTEM AND ACCESSORIES (SURX LP...
K011190 · MUK
Surx, Inc.
Gastroenterology & Urology · 264d
Cleared Jan 08, 2002
BICART
K013724 · KPO
Gambro Renal Products
Gastroenterology & Urology · 60d
Cleared Jan 07, 2002
DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS,...
K011537 · KDI
Dynamic Technology Corp.
Gastroenterology & Urology · 234d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345 · KOD
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 07, 2002
SHARGHP A.V. FISTULA NEEDLE SET
K013384 · FIE
Shargh Pharmaceutical Co., Inc.
Gastroenterology & Urology · 87d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · FGE
Guidant Corp.
Gastroenterology & Urology · 33d
Cleared Jan 04, 2002
PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE...
K013174 · EZL
Porges S.A.
Gastroenterology & Urology · 102d
Cleared Dec 20, 2001
GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES
K012660 · FET
Gimmi GmbH
Gastroenterology & Urology · 129d
Cleared Dec 20, 2001
PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE...
K013172 · EZL
Porges S.A.
Gastroenterology & Urology · 87d
Cleared Dec 19, 2001
MICROGYN PLUS STIMULATION DEVICE
K013141 · KPI
Hollister, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 18, 2001
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
K012088 · KNW
Nastech Pharmaceutical Company, Inc.
Gastroenterology & Urology · 168d
Cleared Dec 12, 2001
BIOSPEED
K013069 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
JAMSHIDI BIOPSY NEEDLE
K013070 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d
Cleared Dec 12, 2001
SECURCUT ASPIRATION BIOPSY NEEDLE
K013071 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 90d