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
4273–4296 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 29, 2000
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION...
K002834 · HIR
Srs Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Nov 22, 2000
SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET
K001563 · FGO
Scion Cardiovascular, Inc.
Gastroenterology & Urology · 187d
Cleared Nov 22, 2000
ENTERIC INJECTION CATHETER WITH IRRIGATION
K002778 · FBK
Enteric Medical Technologies, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 22, 2000
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816 · KOC
Transonic Systems, Inc.
Gastroenterology & Urology · 72d
Cleared Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336 · FGE
Cordis Corp.
Gastroenterology & Urology · 28d
Cleared Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365 · FGE
Cordis Corp.
Gastroenterology & Urology · 26d
Cleared Nov 22, 2000
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · KNW
Allegiance Healthcare Corp.
Gastroenterology & Urology · 23d
Cleared Nov 21, 2000
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 74d
Cleared Nov 16, 2000
ADVANCED UROSCIENCE INNERSHEATH
K002573 · FBK
Advanced Uroscience, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 15, 2000
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685 · MSE
Baxter Healthcare Corp
Gastroenterology & Urology · 167d
Cleared Nov 03, 2000
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND...
K002398 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 01, 2000
MEDOVATIONS ESOPHAGEAL DILATOR
K002363 · KNQ
Medovations, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 31, 2000
CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE
K002546 · KNW
CIVCO Medical Instruments Co., Inc.
Gastroenterology & Urology · 75d
Cleared Oct 30, 2000
NIR BILIARY STENT
K002130 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 108d
Cleared Oct 26, 2000
GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER
K994390 · MSF
Gambro Healthcare
Gastroenterology & Urology · 303d
Cleared Oct 25, 2000
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
K001811 · FIP
Neu-Ion, Inc.
Gastroenterology & Urology · 132d
Cleared Oct 25, 2000
ACCESS ALERT GAUGE
K002372 · KOC
Medisystems Corp.
Gastroenterology & Urology · 82d
Cleared Oct 19, 2000
IMPOAID
K000730 · LKY
Impoaid, Inc.
Gastroenterology & Urology · 227d
Cleared Oct 13, 2000
ENDOCARE PERCUTANEOUS ACCESS SET
K002396 · KOD
Endocare, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 12, 2000
NIR BILLIARY STENT SYSTEM
K002133 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 90d
Cleared Oct 12, 2000
DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
K002143 · FGE
Guidant Corp.
Gastroenterology & Urology · 87d
Cleared Oct 06, 2000
BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
K002094 · ESW
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Oct 05, 2000
RAPID EXCHANGE TAPERTOME
K002802 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 27d
Cleared Sep 29, 2000
BRAVO PH MONITORING SYSTEM
K002028 · FFT
Endonetics, Inc.
Gastroenterology & Urology · 88d