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

Instrument, Catheter, Punch

21 CFR 876.5090 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FEX is the FDA product code for Instrument, Catheter, Punch, a class I device type, regulated under 21 CFR 876.5090. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FEX
Device name
Instrument, Catheter, Punch
Regulation
21 CFR 876.5090
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
0

Clearances, product code FEX

By decision year
2 clearances under product code FEX with a decision year between 1977 and 1991, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FEX by decision year
YearClearances
19771
19911

Applicants with the most clearances

Product code FEX
Applicants holding the most 510(k) clearances under product code FEX
ApplicantClearances
Hgm Medical Laser Systems, Inc.1
Xomed, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code