SUTURE LOCK— 510(k) K964935

Substantially Equivalent

Smith & Nephew Endoscopy, Inc.

FDA 510(k) clearance K964935 for SUTURE LOCK, Substantially Equivalent on 1997-02-25. Applicant: Smith & Nephew Endoscopy, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew Endoscopy, Inc.
Product code: Code KGS
Device class: Class 1
Regulation: 21 CFR 878.4930
Advisory panel: General, Plastic Surgery
Date received: 1996-12-10
Decision date: 1997-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KGS

K030031 — SOFT TISSUE ANCHORING WASHERS2003-01-28
K020480 — RBM2002-03-12
K941740 — ACUFEX ROTATOR CUFF FIXATION BUTTON1995-06-30
K930675 — MITEK CONE WASHER1993-11-09
K904435 — VENTROFIL TENSION RELIEF SUTURE SET1991-08-29

More clearances from Smith & Nephew Endoscopy, Inc.

K103309 — OSTEORAPTOR CURVED 2.3 SUTURE ANCHORS2011-02-03
K102660 — BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS2010-12-13
K093428 — SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR2009-12-17
K083226 — SMITH & NEPHEW PEEK INTERFERENCE SCREW2009-01-30
K083635 — SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW2009-01-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.