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510(k) K201744

Su2ura Approximation Device by Anchora Medical, Ltd. — Product Code OCW

K201744 is an FDA 510(k) premarket notification submitted by Anchora Medical, Ltd. for the device "Su2ura Approximation Device". The FDA issued a decision of Substantially Equivalent on June 17, 2021. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2021
Date Received
June 25, 2020
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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  • K211309 — endomina system (December 7, 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)

FDA data resources