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
7009–7032 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jan 22, 1990
PHOENIX
K895855 · KNS
Medical and Scientific Enterprises, Inc.
Gastroenterology & Urology · 112d
Cleared Jan 22, 1990
PORGES NASOBILIARY DRAIN
K896376 · FGE
Porges Corp.
Gastroenterology & Urology · 77d
Cleared Jan 22, 1990
URETERAL ACCESS SET
K896385 · KOD
Applied Urology, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 22, 1990
PORGES BILIARY STENTS
K896423 · FGE
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 22, 1990
PORGES SPHINCTEROTOMES
K896426 · KNS
Porges Corp.
Gastroenterology & Urology · 75d
Cleared Jan 22, 1990
PORGES BIOPSY & FOREIGN BODY FORCEPS
K896502 · OCZ
Porges Corp.
Gastroenterology & Urology · 68d
Cleared Jan 18, 1990
INAMED RHEMO-D (TM) DILATOR
K894618 · FFP
Inamed Development Co.
Gastroenterology & Urology · 182d
Cleared Jan 18, 1990
CYSTO PUMP DRAINAGE BAG
K896208 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
GASTRIC SUMP TUBE
K896210 · KNT
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
CYSTOSCOPY/IRRIGATION SET
K896211 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 18, 1990
Y-TYPE TUR/CONTINUOUS BLADDER IRRIGATION SET
K896213 · KOD
Westmark, Sterile Packing Systems,...
Gastroenterology & Urology · 84d
Cleared Jan 11, 1990
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS
K893991 · KPO
P & A Co.
Gastroenterology & Urology · 220d
Cleared Jan 11, 1990
AMICON MINIFILTER PLUS HEMOFILTER
K895405 · KDI
Amicon, Inc.
Gastroenterology & Urology · 126d
Cleared Jan 11, 1990
BITOME(TM) BIPOLAR SPHINCTEROTOME
K895842 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 101d
Cleared Jan 11, 1990
WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
K895900 · FCK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Jan 03, 1990
ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
K895417 · LFJ
Arrow Intl., Inc.
Gastroenterology & Urology · 124d
Cleared Dec 28, 1989
GRASPING FORCEPS
K896058 · KOA
Annex Medical, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 27, 1989
DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095
K896006 · KOC
Baxter Healthcare Corp
Gastroenterology & Urology · 75d
Cleared Dec 27, 1989
MODEL 6500 MERCURY ARC LIGHT SOURCE
K896008 · GCP
Medical Dynamics, Inc.
Gastroenterology & Urology · 75d
Cleared Dec 27, 1989
FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB
K896111 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 65d
Cleared Dec 21, 1989
NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR
K894653 · KGC
Superior Biosystems, Inc.
Gastroenterology & Urology · 150d
Cleared Dec 21, 1989
WILTEK GASTRIC FEEDING TUBE
K894860 · FPD
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK PAPILLOTOME
K894861 · KNS
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 21, 1989
WILTEK GRASPING FORCEPS
K894862 · OCZ
Wiltek Medical, Inc.
Gastroenterology & Urology · 143d