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510(k) K240879

EsophyX Z+ Device with SerosaFuse Fasteners and Accessories by Endogastric Solutions, Inc. — Product Code ODE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2024
Date Received
March 29, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To treat the symptoms of chronic gastroesophageal reflux disease (GERD), either by approximating tissue with sutures or plicating tissue with an implant.

Other clearances by Endogastric Solutions, Inc.

  • 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)
  • K062875 — ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES (March 9, 2007)

Other clearances for product code ODE

  • K233240 — GERDX-System (June 21, 2024)
  • 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)
  • K151001 — MUSE System (June 5, 2015)
  • K143645 — EsophyX® Z Fastener Delivery Device (March 4, 2015)
  • K143634 — MUSE System (January 20, 2015)
  • K142113 — ESOPHYX2 HD (September 30, 2014)
  • K132151 — SRS ENDOSCOPIC STAPLING SYSTEM (March 19, 2014)
  • K120299 — SRS ENDOSCOPIC STAPLING SYSTEM (May 18, 2012)