510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K083710Substantially Equivalent

Retractor Lite

Thomas Surgical Instruments, Inc., Traverse City MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083710 is the FDA 510(k) clearance record for RETRACTOR LITE, a class II device, cleared for Thomas Surgical Instruments, Inc. on under FDA product code FST (Light, Surgical, Fiberoptic). FDA records list one 510(k) clearance for Thomas Surgical Instruments, Inc. As of , FDA records show no recalls naming K083710.

Clearance record

Decision date
Received
(70 days to decision)
Product code
FST Light, Surgical, Fiberoptic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Thomas Surgical Instruments, Inc. 10170 E Cherry Bend Rd., Traverse City MI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FST

Trailing 12 months

FDA records hold no clearances under product code FST in the trailing twelve months.

FDA records show no clearances under product code FST in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FST, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260