510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K022989Substantially Equivalent

Radlite Tissue Retractor System

Genzyme Biosurgery, Fall River MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022989 is the FDA 510(k) clearance record for RADLITE TISSUE RETRACTOR SYSTEM, a class II device, cleared for Genzyme Biosurgery on under FDA product code FSW (Light, Surgical, Endoscopic). FDA records list 4 510(k) clearances for Genzyme Biosurgery, from to . As of , FDA records show no recalls naming K022989.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FSW Light, Surgical, Endoscopic
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Genzyme Biosurgery 600 Airport Rd., Fall River MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FSW

Trailing 12 months

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

FDA records show no clearances under product code FSW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FSW, 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