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510(k) K073644

ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES by Endogastric Solutions, Inc. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2008
Date Received
December 26, 2007
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 Endogastric Solutions, Inc.

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  • K172811 — EsophyX Z, EsophyX2 HD (October 19, 2017)
  • K171307 — EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device w (June 22, 2017)
  • K160960 — EsophyX® Z Device with SerosaFuse Fasteners and Accessories (May 1, 2016)
  • K143645 — EsophyX® Z Fastener Delivery Device (March 4, 2015)
  • K142113 — ESOPHYX2 HD (September 30, 2014)
  • K092400 — ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, (November 6, 2009)
  • K091832 — ENDOGASTRIC SOLUTIONS STOMAPHYX SYSTEM WITH SEROSAFUSE FASTENER (July 22, 2009)
  • K071651 — EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIE (September 14, 2007)
  • K062875 — ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES (March 9, 2007)

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  • K213271 — MedicloseTM System (August 31, 2023)
  • K231553 — OverStitch NXT Endoscopic Suturing System (June 29, 2023)
  • K211309 — endomina system (December 7, 2021)
  • K201744 — Su2ura Approximation Device (June 17, 2021)
  • K210266 — OverStitch Sx Endoscopic Suturing System (March 2, 2021)
  • K193652 — AbClose - Port Site Closure Device (March 26, 2020)
  • K191439 — OverStitch 2-0 Polypropylene Suture (August 29, 2019)