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
1561–1584 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 26, 2017
Vesco Medical Nasoenteric Feeding Tubes
K170162 · PIF
Vesco Medical, LLC
Gastroenterology & Urology · 251d
Cleared Sep 20, 2017
Magic3 Go Intermittent Urinary Catheter
K172247 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 56d
Cleared Sep 20, 2017
Tri-Ex Extraction Balloon With Multiple Sizing
K170292 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 232d
Cleared Sep 20, 2017
PENTAX Medical ED34-i10T, Video Duodenoscope
K163614 · FDT
Pentax Medical
Gastroenterology & Urology · 272d
Cleared Sep 19, 2017
Accordion Piccolo Stone Management Device
K172299 · FFL
Ths International, Inc. D/B/A...
Gastroenterology & Urology · 50d
Cleared Sep 15, 2017
Fresenius Liberty Select Cycler
K171652 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 102d
Cleared Sep 14, 2017
Veress Needle
K172120 · FHO
Wickimed (Huizhou) Medical Equipment...
Gastroenterology & Urology · 63d
Cleared Sep 14, 2017
Bard Mission Disposable Core Biopsy Instrument
K171953 · KNW
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 77d
Cleared Sep 14, 2017
Entuit Start Initial Placement Gastrostomy Set
K170323 · KGC
Cook Incorporated
Gastroenterology & Urology · 225d
Cleared Sep 11, 2017
Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow...
K171531 · KNW
Care Fusion
Gastroenterology & Urology · 109d
Cleared Sep 11, 2017
Navina Classic System
K170487 · KNT
Dentsply Sirona
Gastroenterology & Urology · 206d
Cleared Sep 01, 2017
PillCam SBC capsule endoscopy system, PilCam Desktop Software 9.0
K170210 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 220d
Cleared Aug 31, 2017
Medical Video Endoscope System
K172098 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 51d
Cleared Aug 29, 2017
Feminine Personal Trainer (FPT)
K171896 · HIR
Ralston Group
Gastroenterology & Urology · 64d
Cleared Aug 28, 2017
Salle Intraoperative Pyeloplasty Stent Set
K170010 · FAD
Cook Incorporated
Gastroenterology & Urology · 237d
Cleared Aug 24, 2017
NxStage System One
K171331 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 108d
Cleared Aug 23, 2017
Endoscopic Injection Needle
K172227 · FBK
Carbon Medical Technologies, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 21, 2017
ShockPulse-SE Lithotripsy System
K171024 · FEO
Cybersonics, Inc.
Gastroenterology & Urology · 138d
Cleared Aug 18, 2017
UroLift System (UL500)
K172359 · PEW
Neotract, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 17, 2017
Zimmon Needle Knife Papillotome
K171993 · KNS
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 45d
Cleared Aug 17, 2017
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
K171983 · KNS
Creo Medical, Ltd.
Gastroenterology & Urology · 48d
Cleared Aug 17, 2017
U Deliver Bolink ENFit Enteral Feeding Sets
K170555 · PIF
U Deliver Medical, LLC
Gastroenterology & Urology · 174d
Cleared Aug 17, 2017
Ureteral Dilators and Percutaneous Nephrostomy Dilators
K170531 · EZN
Coloplast Corp.
Gastroenterology & Urology · 176d
Cleared Aug 11, 2017
SOZO
K172122 · OBH
ImpediMed Limited
Gastroenterology & Urology · 29d