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510(k) K073671

PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT, PLICATOR GSX SUTURE CARTRIDGE by Ndo Surgical, Inc. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2008
Date Received
December 27, 2007
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 Ndo Surgical, Inc.

  • K072125 — ENDOSCOPIC PLICATION SYSTEM, EPS, EPLICATOR, PLICATOR INSTRUMENT (October 18, 2007)
  • K071553 — ENDOSCOPIC PLICATION SYSTEM; EPS; PLICATOR (September 18, 2007)
  • K032820 — MODIFICATION TO ENDOSCOPIC PLICATION SYSTEM (October 23, 2003)
  • K031262 — ENDOSCOPIC PLICATION SYSTEM, MODEL 160-00760 (May 23, 2003)
  • K023234 — ENDOSCOPIC PLICATION SYSTEM (April 17, 2003)

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  • K213271 — MedicloseTM System (August 31, 2023)
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  • 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)