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

Instrument, Special Lens, For Endoscope

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

FEI is the FDA product code for Instrument, Special Lens, For Endoscope, a class I device type, regulated under 21 CFR 876.1500. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FEI
Device name
Instrument, Special Lens, For Endoscope
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
2
Ingested recalls
2

Clearances, product code FEI

By decision year
2 clearances under product code FEI with a decision year between 1986 and 1988, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FEI by decision year
YearClearances
19861
19881

Applicants with the most clearances

Product code FEI
Applicants holding the most 510(k) clearances under product code FEI
ApplicantClearances
American Edwards Laboratories1
Opto Vision, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order