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

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

21 CFR 878.4820 / General, Plastic Surgery
FDA source (opens on fda.gov)

HWE is the FDA product code for Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, a class I device type, regulated under 21 CFR 878.4820. As of , FDA records hold 76 510(k) clearances under this code, the most recent dated , and 101 recalls.

Classification record

Product code
HWE
Device name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Regulation
21 CFR 878.4820
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
76
Ingested recalls
101

Clearances, product code HWE

By decision year
76 clearances under product code HWE with a decision year between 1976 and 2015, 1994 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code HWE by decision year
YearClearances
19761
19791
19801
19831
19852
19862
19873
19882
19891
19905
19912
19922
199417
19957
199611
19979
19991
20023
20052
20071
20111
20151

Applicants with the most clearances

Product code HWE
Applicants holding the most 510(k) clearances under product code HWE
ApplicantClearances
U.S. Medical Products, Inc.7
Stryker Corp.4
Richard Wolf Medical Instruments Corp.3
Synthes (USA) Products LLC3
United American Medical Co., Inc.3
Adven Medical2
Aesculap Inc2
Buckman Co., Inc.2
Hall Surgical, Division of Zimmer, Inc.2
Neoligaments, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 338 companies shown, in name order