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510(k) K971939

SMITH & NEPHEW SUTURE COLLET by Smith & Nephew Endoscopy, Inc. — Product Code OCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1997
Date Received
May 27, 1997
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 Smith & Nephew Endoscopy, Inc.

  • K103309 — OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS (February 3, 2011)
  • K102660 — BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS (December 13, 2010)
  • K093428 — SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR (December 17, 2009)
  • K083635 — SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW (January 30, 2009)
  • K083226 — SMITH & NEPHEW PEEK INTERFERENCE SCREW (January 30, 2009)
  • K082095 — ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE (October 21, 2008)
  • K050580 — SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS (April 20, 2005)
  • K992396 — BIORCI SCREW (January 12, 2000)
  • K991500 — SMITH & NEPHEW SUTURE LOK (July 14, 1999)
  • K972599 — ACUFEX SCREW CANNULA (September 19, 1997)

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  • K211309 — endomina system (December 7, 2021)
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  • 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)