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510(k) K160117

AbClose - Port Site Closure Device by Medeon Biodesign, Inc. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2016
Date Received
January 19, 2016
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 Medeon Biodesign, Inc.

  • K200902 — ClickClean (April 30, 2020)
  • K193652 — AbClose - Port Site Closure Device (March 26, 2020)
  • K192891 — Laparoscope Lens Shield Device (LENS) (November 7, 2019)
  • K170103 — Laparoscope Lens Shield Device (LENS) (February 16, 2017)
  • K160172 — Laparoscope Lens Shield Device (April 21, 2016)
  • K151117 — Laparoscope Lens Shield Device (August 20, 2015)

Other clearances for product code OCW

  • K252400 — Endomina EZFuse system (February 13, 2026)
  • 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)