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

Tray, Surgical, Needle

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

FSH is the FDA product code for Tray, Surgical, Needle, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FSH
Device name
Tray, Surgical, Needle
Regulation
21 CFR 878.4800
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
Yes
Ingested clearances
8
Ingested recalls
7

Clearances, product code FSH

By decision year
8 clearances under product code FSH with a decision year between 1977 and 1988, 1982 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FSH by decision year
YearClearances
19771
19781
19824
19882

Applicants with the most clearances

Product code FSH
Applicants holding the most 510(k) clearances under product code FSH
ApplicantClearances
American Pharmaseal Div. Ahsc3
Carl Zeiss, Inc.2
Applied Medical Research1
Siemens Healthcare Diagnostics Inc.1
Emerson-Sack-Warner Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order