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)
Top companies in FED
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2015 | K150083 | Sidecar External Working Channel C2 Therapeutics | FED |
| Jul 24, 2014 | K140523 | RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM Coloplast A/S | FED |
| Mar 7, 2014 | K140323 | NAVIGATOR HD URETERAL ACCESS SHEATH SETS Boston Scientific | FED |
| Feb 26, 2014 | K131598 | ANAL RECTAL OVERTUBE United States Endoscopy Group, Inc. | FED |
| Feb 11, 2014 | K133359 | ENDORINGS Endo-Aid, Inc. | FED |
| Mar 22, 2013 | K123013 | ENDOSCOPIC INTRODUCER Novadaq Technologies, Inc., CA | FED |
| Mar 1, 2013 | K123675 | RE-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, 2012 | K122649 | NAVIGATOR HD URETERAL ACCESS SHEATH SET Boston Scientific Corp | FED |
| Sep 28, 2012 | K122270 | OVERTUBE ENDOSCOPIC ACCESS SYSTEM Apollo Endosurgery, Inc. | FED |
| Sep 10, 2012 | K120126 | BAROSENSE ENDOGASTRIC TUBE AND INTRODUCER BOUGIE Barosense, Inc. | FED |
| Sep 4, 2012 | K122565 | ARC ENDOCUFF Boddingtons Plastics, Ltd., GB | FED |
| Oct 6, 2011 | K110531 | ENDOFLIP ECD Crospon, Ltd. | FED |
| Oct 18, 2010 | K102485 | RE-TRACE URETERAL ACCESS SHEATH Coloplast A/S | FED |
| Jun 14, 2010 | K082102 | GASTRIC PORT, MODELS: GAP-0016-00, GAP-0018-00, GAP-0020-00 Apollo Endosurgery, Inc. | FED |
| Apr 12, 2010 | K100081 | ENTEROSCOPY OVERTUBE, MODEL 00712140 United States Endoscopy Group, Inc. | FED |
| Oct 20, 2009 | K092221 | COLONIC SPLINTING OVERTUBE, MODEL 00711145 United States Endoscopy Group, Inc. | FED |
| Oct 14, 2009 | K092156 | CAD 12, COLONOSCOPY ASSIST DEVICE Softscope Medical Technologies, Inc. | FED |
| Aug 7, 2009 | K091773 | FUJINON STERILE OVERTUBES Fujinon, Inc. | FED |
| May 22, 2009 | K082589 | BAROSENSE ENDOGASTRIC TUBE (EGT), MODEL F0034 Barosense, Inc. | FED |
| May 6, 2008 | K080050 | SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE Spirus Medical, Inc. | FED |
| Sep 13, 2007 | K072405 | USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE Usgi Medical | FED |
| Oct 13, 2006 | K062805 | MODIFICATION TO ENDO-EASE Spirus Medical, Inc. | FED |
| Jun 20, 2006 | K061324 | EMT QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH, SERIES 1-7 Rtc Inc.-Memcath Technologies, LLC | FED |
| May 15, 2006 | K061216 | USGI TRANSPORT ENDOSCOPIC GUIDE Usgi Medical | FED |
| Sep 14, 2005 | K052084 | ENDO-EASE ENDOSCOPIC OVERTUBE Spirus Medical, Inc. | FED |
| Jul 26, 2005 | K051919 | MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE Usgi Medical | FED |
| Jun 16, 2005 | K051504 | SPYSCOPE ACCESS AND DELIVERY CATHETER Boston Scientific Corp | FED |
| Mar 31, 2005 | K043418 | COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH Cook Urological, Inc. | FED |
| Feb 28, 2005 | K050253 | USGI SHAPELOCK ENDOSCOPIC GUIDE Usgi Medical | FED |
| Jun 10, 2004 | K040836 | DISPOSABLE OVERTUBE United States Endoscopy Group, Inc. | FED |
| Mar 19, 2004 | K033954 | SHAPE LOCKING ENDOSCOPIC OVERTUBE Usgi Medical, Inc. | FED |
| Dec 30, 2003 | K033778 | MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT C.R. Bard, Inc. | FED |
| Aug 20, 2003 | K023902 | SHAPE-LOCKABLE ENDOSCOPIC OVERTUBE Usgi Medical, Inc. | FED |
| May 23, 2003 | K030956 | NAVIGATOR URETERAL ACCESS SHEATH SET Boston Scientific Corp | FED |
| May 23, 2003 | K030642 | DEFLECTING URETERAL ACCESS SHEATH Applied Medical Resources Corp. | FED |
| Mar 17, 2003 | K030438 | BARD AQUAGUIDE URETERAL CONDUIT C.R. Bard, Inc. | FED |
| Nov 25, 2002 | K022686 | LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE Lap Surgical Systems, LLC | FED |
| Aug 17, 2000 | K002018 | NDO SURGICAL SURGICAL OVERTUBE Surgical, Inc. | FED |
| Dec 28, 1999 | K993650 | URETERAL ACCESS SHEATH SET - NEW MODELS Applied Medical Resources | FED |
| Apr 21, 1999 | K990775 | URETERAL ACCESS SHEATH SET Applied Medical Resources | FED |
| Dec 1, 1998 | K983415 | DELIVERY SHEATH Conway Stuart Medical, Inc. | FED |
| Oct 16, 1997 | K973500 | BARD ENDOSCOPIC OVERTUBE (#000307) C.R. Bard, Inc. | FED |
| Sep 19, 1997 | K972781 | OT-1 Prism Therapeutics, LLC | FED |
| Jul 18, 1994 | K942573 | COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH Richard Hamer Assoc., Inc. | FED |
| Jun 10, 1994 | K942044 | BARD ENDOSCOPIC OVERTUBE C.R. Bard, Inc. | FED |
| Aug 4, 1992 | K921120 | FLEXIBLE CYSTOSCOPY INTRODUCING CATHETER Cook Urological, Inc. | FED |
| Oct 10, 1991 | K912265 | MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000 Medical Laser, Inc. | FED |
| Jan 23, 1991 | K903842 | ST-E1 OVERTUBE Olympus Corp. | FED |
| Feb 14, 1990 | K896680 | PROBE SHEATH FOR ADMS & CAPISTRANO LABS TRANSREC. Interson Corp. | FED |
| May 31, 1989 | K890629 | ESOPHAGEAL OVERTUBE Gastrotech, Inc. | FED |
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