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
5233–5256 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 30, 1996
DALE GASTROSTOMY TUBE HOLDER
K961693 · PLI
Dale Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 30, 1996
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 29, 1996
NHMC URETHRAL CATHETERIZATION TRAY
K962254 · FCM
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 47d
Cleared Jul 24, 1996
DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
K954713 · FGE
Ideas For Medicine, Inc.
Gastroenterology & Urology · 288d
Cleared Jul 24, 1996
DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER
K960176 · FEG
C.R. Bard, Inc.
Gastroenterology & Urology · 190d
Cleared Jul 24, 1996
SUBCUTANEOUS URINARY DIVERSON STENT SET
K961371 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 106d
Cleared Jul 23, 1996
CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
K953875 · MQS
In-Line Diagnostics Corp.
Gastroenterology & Urology · 391d
Cleared Jul 22, 1996
REUSABLE ENDOSCOPIC ACCESSORY HANDLE
K961762 · KNS
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 76d
Cleared Jul 22, 1996
DRYTIME FOR BLADDER CONTROL SILENT
K962416 · KPN
Bio-Systems Research
Gastroenterology & Urology · 83d
Cleared Jul 18, 1996
OLYMPUS BASKET GRASPERS (UROLOGY)
K961611 · OCZ
Olympus America, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 18, 1996
CIRCLE NEPHROSTOMY CATHETER SET
K961933 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 62d
Cleared Jul 18, 1996
XENON LIGHTSOURCE
K962365 · GCT
Dsp Worldwide
Gastroenterology & Urology · 29d
Cleared Jul 18, 1996
PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT...
K962604 · FAQ
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 16d
Cleared Jul 15, 1996
NEEDLE CATHETER
K961846 · FBK
Boston Scientific Corp
Gastroenterology & Urology · 63d
Cleared Jul 15, 1996
COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER
K962384 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 25d
Cleared Jul 15, 1996
COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER
K962413 · EXJ
Sierra Laboratories, Inc.
Gastroenterology & Urology · 24d
Cleared Jul 10, 1996
WALLSTENT ENTERAL ENDOPROTHESIS
K954290 · MQR
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 300d
Cleared Jul 09, 1996
EG-2940, VIDEO GASTROSCOPE
K961564 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1996
ED-344OT
K961568 · FDT
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 77d
Cleared Jul 09, 1996
S-57 VIDEO IMAGING SYSTEM
K962024 · FET
Del Medical Systems Corp.
Gastroenterology & Urology · 47d
Cleared Jul 03, 1996
FRESENIUS BLOOD TEMPERATURE MONITOR
K941460 · MQS
Fresenius USA, Inc.
Gastroenterology & Urology · 831d
Cleared Jun 27, 1996
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
K960173 · FAT
Gabriel Medical, Inc.
Gastroenterology & Urology · 163d
Cleared Jun 27, 1996
LIBERTY LITE PFS SYSTEM
K960496 · KPI
Utah Medical Products, Inc.
Gastroenterology & Urology · 147d
Cleared Jun 26, 1996
CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
K942867 · KPL
Clearwater Colon Hydrotherapy, Inc.
Gastroenterology & Urology · 740d