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510(k) K252400

Endomina EZFuse system by Endo Tools Therapeutics S.A. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2026
Date Received
July 31, 2025
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 Endo Tools Therapeutics S.A.

  • K211309 — endomina system (December 7, 2021)

Other clearances for product code OCW

  • K243750 — SimpleStitch Suturing System (April 17, 2025)
  • K231240 — MaxTack™ Motorized Fixation Device (September 8, 2023)
  • 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)
  • K181141 — OverStitch Endoscopic Suturing System and Accessories (June 27, 2018)