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

Screw, Oral

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

KBW is the FDA product code for Screw, Oral, 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 one recall.

Classification record

Product code
KBW
Device name
Screw, Oral
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
1

Clearances, product code KBW

By decision year
1 clearance under product code KBW with a decision year between 1994 and 1994, 1994 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KBW by decision year
YearClearances
19941

Applicants with the most clearances

Product code KBW
Applicants holding the most 510(k) clearances under product code KBW
ApplicantClearances
Gam Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order