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510(k) K991500

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

K991500 is an FDA 510(k) premarket notification submitted by Smith & Nephew Endoscopy, Inc. for the device "SMITH & NEPHEW SUTURE LOK". The FDA issued a decision of Substantially Equivalent on July 14, 1999. The device falls under product code OCW (Endoscopic Tissue Approximation Device), a Class II device regulated under 21 CFR 876.1500. Smith & Nephew Endoscopy, Inc. has at least 10 other 510(k) clearances on record.

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)

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)

FDA data resources