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

Trephine, Sinus

21 CFR 874.4420 / Ear, Nose, Throat
FDA source (opens on fda.gov)

KBF is the FDA product code for Trephine, Sinus, a class I device type, regulated under 21 CFR 874.4420. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KBF
Device name
Trephine, Sinus
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code KBF

By decision year
1 clearance under product code KBF with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KBF by decision year
YearClearances
19801

Applicants with the most clearances

Product code KBF
Applicants holding the most 510(k) clearances under product code KBF
ApplicantClearances
Boston Medical Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code