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

Passer

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

HWQ is the FDA product code for Passer, a class I device type, regulated under 21 CFR 888.4540. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
HWQ
Device name
Passer
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
9
Ingested recalls
8

Clearances, product code HWQ

By decision year
9 clearances under product code HWQ with a decision year between 1979 and 1997, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HWQ by decision year
YearClearances
19791
19811
19843
19891
19932
19971

Applicants with the most clearances

Product code HWQ
Applicants holding the most 510(k) clearances under product code HWQ
ApplicantClearances
Acufex Microsurgical, Inc.2
Plastafil, Inc.2
3M Company1
Dow Corning Corp. Healthcare Industries Materials1
Instrument Makar, Inc.1
Mitek Products1
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 108 companies shown, in name order