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510(k) K132151

SRS ENDOSCOPIC STAPLING SYSTEM by Medigus , Ltd. — Product Code ODE

K132151 is an FDA 510(k) premarket notification submitted by Medigus , Ltd. for the device "SRS ENDOSCOPIC STAPLING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 19, 2014. The device falls under product code ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)), a Class II device regulated under 21 CFR 876.1500. Medigus , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2014
Date Received
July 11, 2013
Clearance Type
Traditional
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)
  • K143634 — MUSE System (January 20, 2015)
  • K120299 — SRS ENDOSCOPIC STAPLING SYSTEM (May 18, 2012)

Other clearances for product code ODE

  • K233240 — GERDX-System (June 21, 2024)
  • 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)
  • K143634 — MUSE System (January 20, 2015)
  • K142113 — ESOPHYX2 HD (September 30, 2014)
  • K120299 — SRS ENDOSCOPIC STAPLING SYSTEM (May 18, 2012)

FDA data resources