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

Obturator, For Endoscope

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

FEC is the FDA product code for Obturator, For Endoscope, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FEC
Device name
Obturator, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FEC

By decision year
3 clearances under product code FEC with a decision year between 1976 and 2000, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FEC by decision year
YearClearances
19762
20001

Applicants with the most clearances

Product code FEC
Applicants holding the most 510(k) clearances under product code FEC
ApplicantClearances
V. Mueller O.V. Baxter Healthcare Corp.2
Novasys Medical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code