RETRACTOR LITE— 510(k) K083710

Name: FDA 510(k) clearance K083710
Creator: U.S. Food and Drug Administration
Published: 2009-02-23

Substantially Equivalent

Thomas Surgical Instruments, Inc.

FDA 510(k) clearance K083710 for RETRACTOR LITE, Substantially Equivalent on 2009-02-23. Applicant: Thomas Surgical Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Thomas Surgical Instruments, Inc.
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2008-12-15
Decision date: 2009-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Traverse City, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FST

view all

K200874 — TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End2020-06-30
K141330 — ENDO-CORD2014-12-15
K122637 — LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 480899992012-11-01
K113697 — EIGR SURGICAL ILLUMINATION SYSTEM2012-02-10
K113330 — CABLECAP2012-01-12

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