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

Accessories, Photographic, For Endoscope (Exclude Light Sources)

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FEM is the FDA product code for Accessories, Photographic, For Endoscope (Exclude Light Sources), a class I device type, regulated under 21 CFR 876.1500. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
FEM
Device name
Accessories, Photographic, For Endoscope (Exclude Light Sources)
Regulation
21 CFR 876.1500
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
5

Clearances, product code FEM

By decision year
4 clearances under product code FEM with a decision year between 1979 and 1994, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FEM by decision year
YearClearances
19791
19812
19941

Applicants with the most clearances

Product code FEM
Applicants holding the most 510(k) clearances under product code FEM
ApplicantClearances
Polaroid Corp.2
Hydro-Med Products, Inc.1
Reznik Instruments1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 58 companies shown, in name order