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510(k) K102931

G-CINCH SUTURE GRASPER by Usgi Medical — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 2010
Date Received
October 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Tissue Approximation Device
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

Other clearances by Usgi Medical

  • K103688 — G-PROX EZ ENDOSCOPIC GRASPER (January 14, 2011)
  • K102916 — G-CATH TISSUE ANCHOR DELIVERY CATHETER (October 20, 2010)
  • K100251 — G-CATH TISSUE ANCHOR DELIVERY CATHETER, MODELS 205302, 205333 (February 17, 2010)
  • K093018 — G-PROX ENDOSCOPIC GRASPER, MODEL 205333 (October 7, 2009)
  • K072405 — USGI TRANSPORT ENDOSCOPIC ACCESS DEVICE (September 13, 2007)
  • K061276 — G-PROX ENDOSCOPIC GRASPER (December 6, 2006)
  • K061268 — G-LIX TISSUE GRASPER (July 31, 2006)
  • K061216 — USGI TRANSPORT ENDOSCOPIC GUIDE (May 15, 2006)
  • K051919 — MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE (July 26, 2005)
  • K050253 — USGI SHAPELOCK ENDOSCOPIC GUIDE (February 28, 2005)

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  • K193652 — AbClose - Port Site Closure Device (March 26, 2020)
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