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510(k) K062875

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2007
Date Received
September 26, 2006
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)
  • K073644 — ENDOGASTRIC SOLUTIONS STOMAPHYX DEVICE AND ACCESSORIES (June 27, 2008)
  • K071651 — EGS SEROSAFUSE IMPLANTABLE FASTENERS, ASSOCIATED DELIVERY DEVICES AND ACCESSORIE (September 14, 2007)

Other clearances for product code OCW

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  • K243750 — SimpleStitch Suturing System (April 17, 2025)
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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)