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
5521–5544 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 23, 1995
PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER
K952414 · KNY
Acacia Laboratories, Inc.
Gastroenterology & Urology · 31d
Cleared Jun 22, 1995
FILTRYZER
K942681 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 380d
Cleared Jun 15, 1995
STANDARD FOLEY SYSTEM PAK
K951443 · FCN
Trinity Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 15, 1995
CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
K951479 · FCM
Trinity Laboratories, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 15, 1995
ACCESS EXPANSION SYSTEM
K951894 · FHO
Micro-Medical Devices, Inc.
Gastroenterology & Urology · 52d
Cleared Jun 15, 1995
KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS
K952149 · LQR
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 38d
Cleared Jun 15, 1995
RUSCH URODYNAMIC RECTAL BALLOON CATHETER
K952573 · FEN
Rusch Intl.
Gastroenterology & Urology · 10d
Cleared Jun 13, 1995
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K920186 · FIP
Better Water, Inc.
Gastroenterology & Urology · 1246d
Cleared Jun 13, 1995
OLYMPUS NBD TUBES
K944912 · FGE
Olympus America, Inc.
Gastroenterology & Urology · 251d
Cleared Jun 13, 1995
FLEXILOG 2000
K945069 · FFT
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 242d
Cleared Jun 13, 1995
RUSCH INTERNATIONAL URODYNAMIC CATHETERS
K952029 · FEN
Rusch Intl.
Gastroenterology & Urology · 43d
Cleared Jun 09, 1995
CORPAK GASTROSTOMY TUBE
K931921 · KNT
Corpak Co.
Gastroenterology & Urology · 784d
Cleared Jun 07, 1995
GRASSI GASTROJEJUNOSTOMY TUBE
K932880 · KNT
Bissell Medical Products, Inc.
Gastroenterology & Urology · 723d
Cleared Jun 07, 1995
MRI'S ALL SILICONE GASTROSTOMY TUBE
K951489 · KNT
Manufacturing & Research, Inc.
Gastroenterology & Urology · 68d
Cleared Jun 06, 1995
ELITE BIOFEEDBACK
K942563 · HIR
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 371d
Cleared Jun 06, 1995
NEPHRO-URETERAL STENT
K942688 · LJE
Uresil Corp.
Gastroenterology & Urology · 364d
Cleared Jun 06, 1995
SURGACTIVATOR
K951569 · LJH
Deschutes Medical Products, Inc.
Gastroenterology & Urology · 63d
Cleared Jun 01, 1995
DYNABITE UROLOGICAL FORCEPS
K952391 · FCL
Portlyn Corp.
Gastroenterology & Urology · 10d
Cleared May 30, 1995
CONTINUOUS FLOW BIOPSY PROBE
K942626 · FDC
Gm Engineering, Inc.
Gastroenterology & Urology · 362d
Cleared May 30, 1995
ALTRA NOVA(TM) 170 HEMODIALYZER
K945621 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 196d
Cleared May 30, 1995
ALTRA NOVA(TM) 140 HEMODIALYZER
K945625 · KDI
Althin Medical AB an Affiliate of...
Gastroenterology & Urology · 196d
Cleared May 30, 1995
URETHRAL CATHETERIZATION TRAY
K950390 · FCM
Medcare Custom Packaging, Inc.
Gastroenterology & Urology · 118d
Cleared May 30, 1995
FCN-15X, FIBER CHOLEDOCHONEPHROSCOPE
K951191 · FBN
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 75d
Cleared May 30, 1995
FE-24X, FIBER ESOPHAGOSCOPE
K951197 · GCL
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 75d