Retractor Lite

FDA 510(k) K083710 · Thomas Surgical Instruments, Inc.

Substantially Equivalent

510(k) numberK083710

Submission

Device name
Retractor Lite
Applicant
Thomas Surgical Instruments, Inc.
Traverse City, MI, US
Received
December 15, 2008
Decision date
February 23, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FST – Light, Surgical, Fiberoptic
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

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Questions and answers

When was Retractor Lite cleared by the FDA?

Retractor Lite (K083710) received a 510(k) decision of Substantially Equivalent on February 23, 2009, 70 days after the submission was received.

What is the product code of K083710?

The FDA product code is FST – Light, Surgical, Fiberoptic, a Class II (moderate risk) device regulated under 21 CFR 878.4580.