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510(k) K143634

MUSE System by Medigus , Ltd. — Product Code ODE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2015
Date Received
December 22, 2014
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 Medigus , Ltd.

  • K151001 — MUSE System (June 5, 2015)
  • K132151 — SRS ENDOSCOPIC STAPLING SYSTEM (March 19, 2014)
  • K120299 — SRS ENDOSCOPIC STAPLING SYSTEM (May 18, 2012)

Other clearances for product code ODE

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  • K240879 — EsophyX Z+ Device with SerosaFuse Fasteners and Accessories (April 26, 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)
  • K142113 — ESOPHYX2 HD (September 30, 2014)
  • K132151 — SRS ENDOSCOPIC STAPLING SYSTEM (March 19, 2014)
  • K120299 — SRS ENDOSCOPIC STAPLING SYSTEM (May 18, 2012)