Home / 510(k) Clearances / K172775

510(k) K172775

MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle by Teleflexmedical, Inc. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2018
Date Received
September 14, 2017
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.

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  • K193652 — AbClose - Port Site Closure Device (March 26, 2020)
  • K191439 — OverStitch 2-0 Polypropylene Suture (August 29, 2019)