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

Table, Operating-Room, Manual

21 CFR 878.4950 / General, Plastic Surgery
FDA source (opens on fda.gov)

FSE is the FDA product code for Table, Operating-Room, Manual, a class I device type, regulated under 21 CFR 878.4950. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FSE
Device name
Table, Operating-Room, Manual
Regulation
21 CFR 878.4950
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
13
Ingested recalls
1

Clearances, product code FSE

By decision year
13 clearances under product code FSE with a decision year between 1976 and 1986, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FSE by decision year
YearClearances
19761
19783
19791
19801
19822
19832
19842
19861

Applicants with the most clearances

Product code FSE
Applicants holding the most 510(k) clearances under product code FSE
ApplicantClearances
Devon Industries, Inc.3
Anago, Inc.1
Aspen Laboratories, Inc.1
Emerson-Sack-Warner Corp.1
Healthmate, Inc.1
Innovative Surgical Products, Inc.1
Intl. Management Services, Inc.1
Mizuho Orthopedic Systems Inc1
Porex Medical1
Surgi-Quip Inc.U1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 49 companies shown, in name order