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
6985–7008 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 09, 1990
WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
K885309 · ESW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 408d
Cleared Feb 09, 1990
SUCTION BIOPSY INSTRUMENT
K895420 · FCK
Mill-Rose Laboratory
Gastroenterology & Urology · 161d
Cleared Feb 09, 1990
FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER
K895506 · LFJ
Vas-Cath, Inc.
Gastroenterology & Urology · 150d
Cleared Feb 09, 1990
CONVEEN INTERMITTENT CATHETERS
K895548 · KOD
Coloplast A/S
Gastroenterology & Urology · 149d
Cleared Feb 09, 1990
JMS DIALYZER PRIMING SET
K895882 · KOC
Jms Co., Ltd.
Gastroenterology & Urology · 127d
Cleared Feb 09, 1990
AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING
K895885 · FCI
National-Standard Co.
Gastroenterology & Urology · 127d
Cleared Feb 08, 1990
METAL URETERAL BASKET STONE DISLODGER
K896992 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 59d
Cleared Feb 02, 1990
DOBBHOFF(R) ERCP CANNULA
K896518 · FGE
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 79d
Cleared Jan 31, 1990
PEDIATRIC DRAIN BAG
K896581 · FFH
Laytech Medical Co.
Gastroenterology & Urology · 75d
Cleared Jan 31, 1990
ARTERIOVENOUS FISTULA SETS
K900125 · FIE
Baxter Healthcare Corp
Gastroenterology & Urology · 22d
Cleared Jan 30, 1990
PORGES ERCP CATHETERS
K896503 · FGE
Porges Corp.
Gastroenterology & Urology · 76d
Cleared Jan 30, 1990
PORGES UNIVERSAL HANDLES
K896505 · GCP
Porges Corp.
Gastroenterology & Urology · 76d
Cleared Jan 29, 1990
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466
K895631 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 132d
Cleared Jan 29, 1990
CONNECTION SHIELDS CODES 5C4213 AND 5C4215
K895673 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 131d
Cleared Jan 29, 1990
MODIFIED QUINTON SINGLE LUMEN CATHETER
K896252 · MPB
Quinton, Inc.
Gastroenterology & Urology · 91d
Cleared Jan 29, 1990
PORGES CYTOLOGY BRUSHES
K896425 · FDX
Porges Corp.
Gastroenterology & Urology · 82d
Cleared Jan 29, 1990
PORGES DIATHERMY SNARE
K896507 · KNS
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 29, 1990
EASI-LAV ADULT GASTRIC LAVAGE KIT
K896573 · KDH
Clairson Industries, LLC
Gastroenterology & Urology · 70d
Cleared Jan 26, 1990
PORGES SCLEROTHERAPY NEEDLES
K896424 · FBK
Porges Corp.
Gastroenterology & Urology · 79d
Cleared Jan 26, 1990
PORGES 2-WAY BALLOON EXTRACTION CATHETER
K896504 · FGE
Porges Corp.
Gastroenterology & Urology · 72d
Cleared Jan 26, 1990
PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
K896506 · FGE
Porges Corp.
Gastroenterology & Urology · 72d
Cleared Jan 24, 1990
SURGICAL GLOVES
K895080 · FGO
Jet Far Industries, Inc.
Gastroenterology & Urology · 163d
Cleared Jan 24, 1990
URETHRAL CATHETERIZATION TRAYS
K896212 · FCM
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 90d
Cleared Jan 22, 1990
SURGEON'S GLOVES
K893522 · FGO
Thai Fuji Latex Co., Ltd.
Gastroenterology & Urology · 259d