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

Awl

21 CFR 888.4540 / Orthopedic
FDA source (opens on fda.gov)

HWJ is the FDA product code for Awl, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 26 recalls.

Classification record

Product code
HWJ
Device name
Awl
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
26

Clearances, product code HWJ

By decision year
4 clearances under product code HWJ with a decision year between 1987 and 1990, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HWJ by decision year
YearClearances
19871
19882
19901

Applicants with the most clearances

Product code HWJ
Applicants holding the most 510(k) clearances under product code HWJ
ApplicantClearances
Buckman Co., Inc.2
Cross Medical Products, Inc.1
Danninger Medical Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 301 companies shown, in name order