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Panels › Gastroenterology, Urology › Product code FED · Class 2

Endoscopic Access Overtube, Gastroenterology-Urology

Regulation 876.1500

6510(k)s in 12 months (105 all time)
0recalls in 12 months (12 all time)
9recalls that name a 510(k)
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Top companies in FED

Decided510(k)Device and applicantCode
Apr 14, 2015K150083Sidecar External Working Channel
C2 Therapeutics
FED
Jul 24, 2014K140523RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
Coloplast A/S
FED
Mar 7, 2014K140323NAVIGATOR HD URETERAL ACCESS SHEATH SETS
Boston Scientific
FED
Feb 26, 2014K131598ANAL RECTAL OVERTUBE
United States Endoscopy Group, Inc.
FED
Feb 11, 2014K133359ENDORINGS
Endo-Aid, Inc.
FED
Mar 22, 2013K123013ENDOSCOPIC INTRODUCER
Novadaq Technologies, Inc., CA
FED
Mar 1, 2013K123675RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
Coloplast A/S
FED
Dec 12, 2012K122649NAVIGATOR HD URETERAL ACCESS SHEATH SET
Boston Scientific Corp
FED
Sep 28, 2012K122270OVERTUBE ENDOSCOPIC ACCESS SYSTEM
Apollo Endosurgery, Inc.
FED
Sep 10, 2012K120126BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE
Barosense, Inc.
FED
Sep 4, 2012K122565ARC ENDOCUFF
Boddingtons Plastics, Ltd., GB
FED
Oct 6, 2011K110531ENDOFLIP ECD
Crospon, Ltd.
FED
Oct 18, 2010K102485RE-TRACE URETERAL ACCESS SHEATH
Coloplast A/S
FED
Jun 14, 2010K082102GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00
Apollo Endosurgery, Inc.
FED
Apr 12, 2010K100081ENTEROSCOPY OVERTUBE, MODEL 00712140
United States Endoscopy Group, Inc.
FED
Oct 20, 2009K092221COLONIC SPLINTING OVERTUBE, MODEL 00711145
United States Endoscopy Group, Inc.
FED
Oct 14, 2009K092156CAD 12, COLONOSCOPY ASSIST DEVICE
Softscope Medical Technologies, Inc.
FED
Aug 7, 2009K091773FUJINON STERILE OVERTUBES
Fujinon, Inc.
FED
May 22, 2009K082589BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034
Barosense, Inc.
FED
May 6, 2008K080050SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
Spirus Medical, Inc.
FED
Sep 13, 2007K072405USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE
Usgi Medical
FED
Oct 13, 2006K062805MODIFICATION TO ENDO-EASE
Spirus Medical, Inc.
FED
Jun 20, 2006K061324EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7
Rtc Inc.-Memcath Technologies, LLC
FED
May 15, 2006K061216USGI TRANSPORT ENDOSCOPIC GUIDE
Usgi Medical
FED
Sep 14, 2005K052084ENDO-EASE ENDOSCOPIC OVERTUBE
Spirus Medical, Inc.
FED
Jul 26, 2005K051919MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
Usgi Medical
FED
Jun 16, 2005K051504SPYSCOPE ACCESS AND DELIVERY CATHETER
Boston Scientific Corp
FED
Mar 31, 2005K043418COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
Cook Urological, Inc.
FED
Feb 28, 2005K050253USGI SHAPELOCK ENDOSCOPIC GUIDE
Usgi Medical
FED
Jun 10, 2004K040836DISPOSABLE OVERTUBE
United States Endoscopy Group, Inc.
FED
Mar 19, 2004K033954SHAPE LOCKING ENDOSCOPIC OVERTUBE
Usgi Medical, Inc.
FED
Dec 30, 2003K033778MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
C.R. Bard, Inc.
FED
Aug 20, 2003K023902SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE
Usgi Medical, Inc.
FED
May 23, 2003K030956NAVIGATOR URETERAL ACCESS SHEATH SET
Boston Scientific Corp
FED
May 23, 2003K030642DEFLECTING URETERAL ACCESS SHEATH
Applied Medical Resources Corp.
FED
Mar 17, 2003K030438BARD AQUAGUIDE URETERAL CONDUIT
C.R. Bard, Inc.
FED
Nov 25, 2002K022686LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
Lap Surgical Systems, LLC
FED
Aug 17, 2000K002018NDO SURGICAL SURGICAL OVERTUBE
Surgical, Inc.
FED
Dec 28, 1999K993650URETERAL ACCESS SHEATH SET - NEW MODELS
Applied Medical Resources
FED
Apr 21, 1999K990775URETERAL ACCESS SHEATH SET
Applied Medical Resources
FED
Dec 1, 1998K983415DELIVERY SHEATH
Conway Stuart Medical, Inc.
FED
Oct 16, 1997K973500BARD ENDOSCOPIC OVERTUBE (#000307)
C.R. Bard, Inc.
FED
Sep 19, 1997K972781OT-1
Prism Therapeutics, LLC
FED
Jul 18, 1994K942573COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH
Richard Hamer Assoc., Inc.
FED
Jun 10, 1994K942044BARD ENDOSCOPIC OVERTUBE
C.R. Bard, Inc.
FED
Aug 4, 1992K921120FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER
Cook Urological, Inc.
FED
Oct 10, 1991K912265MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000
Medical Laser, Inc.
FED
Jan 23, 1991K903842ST-E1 OVERTUBE
Olympus Corp.
FED
Feb 14, 1990K896680PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC.
Interson Corp.
FED
May 31, 1989K890629ESOPHAGEAL OVERTUBE
Gastrotech, Inc.
FED

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