510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K874241Substantially Equivalent

Opmi Md Surgical Microscope

Carl Zeiss, Inc., Thornwood NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874241 is the FDA 510(k) clearance record for OPMI MD SURGICAL MICROSCOPE, a class I device, cleared for Carl Zeiss, Inc. on under FDA product code FSO (Microscope, Surgical, General & Plastic Surgery). FDA records list 44 510(k) clearances for Carl Zeiss, Inc., from to . As of , FDA records show no recalls naming K874241.

Clearance record

Decision date
Received
(69 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
Carl Zeiss, Inc. One Zeiss Dr., Thornwood NY
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