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
8497–8520 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 21, 1984
PROFILE URODYNAMIC MONITORING SYS
K834503 · FAP
Browne Medical, Inc.
Gastroenterology & Urology · 62d
Cleared Feb 21, 1984
SANDMILL RMS
K834512 · FFT
Sandhill Scientific, Inc.
Gastroenterology & Urology · 62d
Cleared Feb 21, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224 · FKX
Travenol Laboratories, S.A.
Gastroenterology & Urology · 33d
Cleared Feb 21, 1984
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT
K840436 · FIQ
Renal Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 21, 1984
HEMASITE ACCESSORIES MODIFICATION
K840437 · KNZ
Renal Systems, Inc.
Gastroenterology & Urology · 20d
Cleared Feb 21, 1984
MALE INSERT SLIP
K840482 · EYQ
Beghin_Say Intl., Inc.
Gastroenterology & Urology · 15d
Cleared Feb 13, 1984
ENTERNAL FEEDING TUBE
K834562 · KNT
Sheridan Catheter Corp.
Gastroenterology & Urology · 47d
Cleared Feb 10, 1984
PERCUTANEOUS RETROGRADE NEPHROSTOMY
K833762 · LJE
Vpi
Gastroenterology & Urology · 107d
Cleared Feb 10, 1984
URIHESIVE SYSTEM - IMPROVED
K834337 · KNX
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 60d
Cleared Feb 10, 1984
URINARY DRAINAGE CONTAINER
K834448 · KNX
Vital Metrics, Inc.
Gastroenterology & Urology · 56d
Cleared Feb 10, 1984
ETHOX WEIGHTED FEEDING TUBE
K834554 · KNT
Ethox Corp.
Gastroenterology & Urology · 45d
Cleared Feb 10, 1984
K-TUBE REPAIR KIT
K840019 · KNT
Midwest Metabolic Support Group
Gastroenterology & Urology · 36d
Cleared Feb 09, 1984
CAPD PREP KIT
K833780 · FKG
Professional Dialysis Products
Gastroenterology & Urology · 104d
Cleared Feb 07, 1984
MEDILAS LASER
K833557 · LNK
Endo Lase, Inc.
Gastroenterology & Urology · 123d
Cleared Feb 06, 1984
REDY 2000
K840743
Organon Teknika Corp.
Gastroenterology & Urology
Cleared Feb 04, 1984
HEMOFILTRATION SYSTEM
K831784 · KDI
Gambro, Inc.
Gastroenterology & Urology · 247d
Cleared Feb 04, 1984
FEEDING GASTROSTOMY TUBE
K832093 · KNT
Tri-Med, Inc.
Gastroenterology & Urology · 221d
Cleared Feb 04, 1984
UROMETER
K833043 · FFG
Browne Medical, Inc.
Gastroenterology & Urology · 151d
Cleared Feb 04, 1984
TWO CHANNEL GASTROFIBERSCOPE FG-36T
K833924 · FDS
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 82d
Cleared Feb 04, 1984
SUPERIOR ENTERNAL FEEDING SYSTEM
K833947 · KNT
Superior Plastic Products Corp.
Gastroenterology & Urology · 81d
Cleared Feb 04, 1984
HODGE DECOMPRESSION TUBE
K834258 · KNT
Inmed Corp.
Gastroenterology & Urology · 59d
Cleared Feb 04, 1984
ISLAMI GASTROINTESTINAL TUBE
K834268 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 58d
Cleared Feb 04, 1984
ADULT INCONTINENCE PAD
K834295 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 58d
Cleared Feb 04, 1984
ADULT INCONTINENCE BRIEF
K834296 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 58d