510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941399Substantially Equivalent

Operating Microscope Aa Om 10

Appasamy Associates (U.S.A.), Inc., Millersville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941399 is the FDA 510(k) clearance record for OPERATING MICROSCOPE AA OM 10, a class I device, cleared for Appasamy Associates (U.S.A.), Inc. on under FDA product code FSO (Microscope, Surgical, General & Plastic Surgery). FDA records list one 510(k) clearance for Appasamy Associates (U.S.A.), Inc. As of , FDA records show no recalls naming K941399.

Clearance record

Decision date
Received
(31 days to decision)
Product code
FSO Microscope, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4700
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Appasamy Associates (U.S.A.), Inc. 193 Rock Ridge Rd., Millersville MD
510(k) summary
Statement
Third party review
No

Clearances, product code FSO

Trailing 12 months

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

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