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

Bougie, Urological

21 CFR 876.5520 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FAX is the FDA product code for Bougie, Urological, a class I device type, regulated under 21 CFR 876.5520. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FAX
Device name
Bougie, Urological
Regulation
21 CFR 876.5520
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 FAX

By decision year
2 clearances under product code FAX with a decision year between 1982 and 1995, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FAX by decision year
YearClearances
19821
19951

Applicants with the most clearances

Product code FAX
Applicants holding the most 510(k) clearances under product code FAX
ApplicantClearances
Karl Storz Endoscopy-America, Inc.1
Parker Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order