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

Microscope, Surgical, General & Plastic Surgery

21 CFR 878.4700 / General, Plastic Surgery
FDA source (opens on fda.gov)

FSO is the FDA product code for Microscope, Surgical, General & Plastic Surgery, a class I device type, regulated under 21 CFR 878.4700. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
FSO
Device name
Microscope, Surgical, General & Plastic Surgery
Regulation
21 CFR 878.4700
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
17

Clearances, product code FSO

By decision year
15 clearances under product code FSO with a decision year between 1979 and 1994, 1993 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FSO by decision year
YearClearances
19791
19802
19823
19871
19901
19911
19934
19942

Applicants with the most clearances

Product code FSO
Applicants holding the most 510(k) clearances under product code FSO
ApplicantClearances
JEDMED Instrument Company4
Kelleher Corp.2
Moeller Microsurgical, Inc.2
Appasamy Associates (U.S.A.), Inc.1
Carl Zeiss, Inc.1
Deemed, Inc.1
Elmed, Inc.1
Teknar, Inc.1
Treace Medical, Inc.1
Woodlyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order