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510(k) K991500

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1999
Date Received
April 29, 1999
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)
  • K972599 — ACUFEX SCREW CANNULA (September 19, 1997)
  • K971939 — SMITH & NEPHEW SUTURE COLLET (August 6, 1997)

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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)