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
7249–7272 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 30, 1989
DRIPRIDE ULTRA INCONTINENT PAD
K883895 · EYQ
Weyerhaeuser Co.
Gastroenterology & Urology · 138d
Cleared Jan 30, 1989
BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS
K884725 · KPO
Baxter Healthcare Corp
Gastroenterology & Urology · 81d
Cleared Jan 27, 1989
MICROSURGICAL CYSTOTOME
K890218 · KOA
Kinetic Medical Products
Gastroenterology & Urology · 9d
Cleared Jan 26, 1989
EURO-COLLINS SOLUTION SETS
K884609 · KDL
Fresenius USA, Inc.
Gastroenterology & Urology · 80d
Cleared Jan 13, 1989
SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER
K884900 · KNW
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 51d
Cleared Jan 11, 1989
CIRCON ACMI BICAP III THERAPEUTIC SYSTEM
K884254 · KNS
Circon Acmi
Gastroenterology & Urology · 92d
Cleared Jan 10, 1989
CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20
K884252 · KNS
Circon Acmi
Gastroenterology & Urology · 91d
Cleared Jan 06, 1989
BARD(R) ASPIRATION BIOPSY SYSTEM
K883469 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 144d
Cleared Jan 05, 1989
BICAP ABLATING FORCEPS BAF-7
K884306 · KNS
Circon Acmi
Gastroenterology & Urology · 84d
Cleared Dec 28, 1988
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
K884153 · FGB
Candela Laser Corp.
Gastroenterology & Urology · 89d
Cleared Dec 27, 1988
TRANSLUMINAL ENDARTERECTOMY DEVICE
K884154 · LIF
Thomas J. Fogarty, M.D.
Gastroenterology & Urology · 85d
Cleared Dec 22, 1988
HEMODIALYSIS CONCENTRATES
K883068 · KPO
Dove Medical Supplies
Gastroenterology & Urology · 155d
Cleared Dec 22, 1988
HEMORX COLD PACK
K883984 · LKX
Bio-Dyne, Inc.
Gastroenterology & Urology · 93d
Cleared Dec 22, 1988
FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT
K884275 · KNT
Abbott Laboratories
Gastroenterology & Urology · 71d
Cleared Dec 19, 1988
DOUBLE CLOSED URINARY DRAINAGE SYSTEM
K883886 · FCN
Knight Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Dec 08, 1988
MODIFIED L.J.'S SEX HELPER
K882531 · LKY
L.J. Fant & Co.
Gastroenterology & Urology · 169d
Cleared Dec 08, 1988
ODOR-END EMERGENCY CLEAN UP POWDER
K882878 · EXB
Cdc Products Corp.
Gastroenterology & Urology · 150d
Cleared Dec 08, 1988
TRANSENDOSCOPIC ASPIRATION NEEDLE
K883093 · FBK
Endovations
Gastroenterology & Urology · 139d
Cleared Dec 08, 1988
IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
K883592 · LFJ
Impra, Inc.
Gastroenterology & Urology · 107d
Cleared Dec 08, 1988
LAKE N/G EXTENSION SET
K884128 · KNT
Lake Medical Products, Inc.
Gastroenterology & Urology · 69d
Cleared Dec 08, 1988
BLOOD TUBING SET
K884243 · FJK
Mediflex Intl.
Gastroenterology & Urology · 58d
Cleared Dec 08, 1988
NH PEDIATRIC REPLACEMENT GASTROSTOMY KIT
K884309 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 08, 1988
ULTRX(TM) 850 ARTIFICIAL KIDNEY
K884353 · KDI
Cd Medical, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 08, 1988
MULTIFLOW(TM) 60 KIT
K884365 · KDI
Hospal Medical Corp.
Gastroenterology & Urology · 51d