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
7321–7344 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 11, 1988
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581 · FFX
Synectics-Dantec
Gastroenterology & Urology · 183d
Cleared Aug 11, 1988
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K880767 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 167d
Cleared Aug 11, 1988
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678 · KNX
Hollister, Inc.
Gastroenterology & Urology · 114d
Cleared Aug 11, 1988
SURGITEK CO2 DELIVERY SYSTEM
K881736 · FAP
Medical Engineering Corp.
Gastroenterology & Urology · 111d
Cleared Aug 11, 1988
MODEL 90DX MULTITEST METER
K882032 · FLB
Mesa Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 09, 1988
FOLEY-TEMP(TM)
K882130 · EYB
Mallinckroot, Inc.
Gastroenterology & Urology · 81d
Cleared Aug 04, 1988
BALL TIP FULGURATING ELECTRODE, 3 FRENCH
K880748 · KNS
Cook Urological, Inc.
Gastroenterology & Urology · 162d
Cleared Aug 02, 1988
CATHETER STRAP
K881781 · KOD
Baxter Healthcare Corp
Gastroenterology & Urology · 98d
Cleared Aug 02, 1988
ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM
K881981 · KOD
Ryder Intl. Corp.
Gastroenterology & Urology · 82d
Cleared Aug 02, 1988
PANAMEX(TM) URETERAL STENT
K882157 · FAD
Kingston Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Aug 02, 1988
COMFORT CATH MALE EXTERNAL CATHETER
K883057 · EYT
Sierra Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 02, 1988
VPI NON-ADHESIVE CONDOM CATHETER
K883119 · EYT
Cook Urological, Inc.
Gastroenterology & Urology · 8d
Cleared Jul 29, 1988
GENT-L-KARE STERILE URINARY LEG BAG
K881217 · KNX
Geneva Laboratories, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 28, 1988
GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
K881213 · KNX
Geneva Laboratories, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 28, 1988
GENT-L-KARE CLEANSING ENEMA SET
K881218 · FCE
Geneva Laboratories, Inc.
Gastroenterology & Urology · 128d
Cleared Jul 28, 1988
CATHETER WITHDRAWAL UNIT
K881878 · KNY
Eris Medical Technology
Gastroenterology & Urology · 85d
Cleared Jul 28, 1988
SIGMA 1 WOBBLER BIOPSY KIT
K882673 · FCH
Kontron Instruments, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 26, 1988
BATTERY PACKS (OTHER THAN CV)
K881885 · FCP
Dowit Service Co., Inc.
Gastroenterology & Urology · 83d
Cleared Jul 25, 1988
CONTINUOUS ARTERIAL/VENOUS HEMOFILTRATION TRAY
K880775 · LFK
Medsurg Industries, Inc.
Gastroenterology & Urology · 150d
Cleared Jul 22, 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 23d
Cleared Jul 21, 1988
ACUSON TRANSRECTAL NEEDLE GUIDE FOR INTRA. APPLI.
K882549 · FCG
Acuson Corp.
Gastroenterology & Urology · 31d
Cleared Jul 20, 1988
JIMMY JOHN III
K881720 · KPL
Colon Therapeutics
Gastroenterology & Urology · 90d
Cleared Jul 15, 1988
MEDSURG ACUTE DIALYSIS TRAY
K880778 · LFJ
Medsurg Industries, Inc.
Gastroenterology & Urology · 140d
Cleared Jul 13, 1988
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
K881636 · EXB
Coloplast A/S
Gastroenterology & Urology · 90d