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Srs Endoscopic Stapling System

by Medigus, Ltd. 2 variants

510(k) K132151

Srs Endoscopic Stapling System is a Class II device made by Medigus, Ltd., cleared under FDA 510(k) K132151 on 19 Mar 2014, active as of 9 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 9 Oct 2026.

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK132151 Date19 Mar 2014ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ODE
FDA applicant
Medigus , Ltd.
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code ODE (Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd)).

Other devices from Medigus, Ltd.

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