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
7129–7152 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 23, 1989
KENDALL KENGUARD URINARY LEG BAGS
K892437 · KNX
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
KENDALL CURITY STOMACH TUBES
K892439 · KNT
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
KENDALL CURITY URETHRAL CATHETERS
K892442 · GBM
The Kendal Co.
Gastroenterology & Urology · 74d
Cleared Jun 23, 1989
CATHETERS, MALE, FEMALE
K892691 · KOD
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 22, 1989
TERUMO AV FISTULA NEEDLE SET
K891062 · FIE
Terumo Medical Corp.
Gastroenterology & Urology · 113d
Cleared Jun 22, 1989
NO. 86500 - ENDOSCOPIC JET WASHER
K892426 · OCX
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 73d
Cleared Jun 22, 1989
BIOPRIME TM KIT
K892932 · FJK
Hospal
Gastroenterology & Urology · 62d
Cleared Jun 22, 1989
CUFF SPECULUM
K893531 · KPL
Mountain Medical Equipment, Inc.
Gastroenterology & Urology · 45d
Cleared Jun 14, 1989
ENTERAL FEEDING CONTAINER
K890424 · KNT
Multi-Med, Inc.
Gastroenterology & Urology · 139d
Cleared Jun 13, 1989
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
K893439 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 12, 1989
PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
K890072 · KNY
Medireach, Inc.
Gastroenterology & Urology · 154d
Cleared Jun 09, 1989
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477 · FJI
Terumo Medical Corp.
Gastroenterology & Urology · 85d
Cleared Jun 08, 1989
DUAL LUMEN SUB-CLAVIAN CATHETER, DLSC 600 & 800
K891753 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 08, 1989
DUAL LUMEN SUB-CLAVIAN CATH KIT, DLSC 600K & 800K
K891755 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 08, 1989
QUINTON SINGLE LUMEN CATHETER
K893188 · MPB
Quinton, Inc.
Gastroenterology & Urology · 34d
Cleared Jun 08, 1989
DELCLAMP
K893231 · KDJ
Delmed, Inc.
Gastroenterology & Urology · 41d
Cleared Jun 08, 1989
T SERIES VESSEL TIPS
K893438 · FKW
Akcess Medical Products, Inc.
Gastroenterology & Urology · 36d
Cleared Jun 08, 1989
DA-16 AND DA-24 SHUNT ADAPTERS
K893478 · FKN
Akcess Medical Products, Inc.
Gastroenterology & Urology · 35d
Cleared Jun 02, 1989
ENTAINER(TM) ENTERAL FEEDING CONTAINER
K890430 · KNT
Entech, Inc.
Gastroenterology & Urology · 127d
Cleared Jun 02, 1989
IRRI-FLO IRRIGATION DELIVERY SYSTEM
K891339 · OCX
Surgitek
Gastroenterology & Urology · 84d
Cleared Jun 01, 1989
MDL-1 LASERTRIPTER(TM)
K885255 · FFK
Candela Laser Corp.
Gastroenterology & Urology · 160d
Cleared May 31, 1989
ESOPHAGEAL OVERTUBE
K890629 · FED
Gastrotech, Inc.
Gastroenterology & Urology · 110d
Cleared May 31, 1989
LIB SYSTEM, BABY/ADULT DIAPER
K891686 · EYQ
Intera Corp.
Gastroenterology & Urology · 70d
Cleared May 31, 1989
ENDO-SPONGE
K892218 · MNL
Endovations
Gastroenterology & Urology · 58d