510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883480Substantially Equivalent

Modified Site Fiber Optic Module for Ophthal. Use

Site Microsurgical Systems, Inc., Horsham PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883480 is the FDA 510(k) clearance record for MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE, a class II device, cleared for Site Microsurgical Systems, Inc. on under FDA product code FCT (Headlight, Fiberoptic Focusing). FDA records list 30 510(k) clearances for Site Microsurgical Systems, Inc., from to . As of , FDA records show no recalls naming K883480.

Clearance record

Decision date
Received
(8 days to decision)
Product code
FCT Headlight, Fiberoptic Focusing
Regulation
21 CFR 886.4335
Device class
Class II
Review panel
Ophthalmic
Applicant
Site Microsurgical Systems, Inc. 135 Gibraltar Rd., Horsham PA
Third party review
No

Clearances, product code FCT

Trailing 12 months

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

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