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

Expander, Breast, External

21 CFR 890.5660 / Physical Medicine
FDA source (opens on fda.gov)

MWZ is the FDA product code for Expander, Breast, External, a class I device type, regulated under 21 CFR 890.5660. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MWZ
Device name
Expander, Breast, External
Regulation
21 CFR 890.5660
Device class
Class I
Review panel
Physical Medicine
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code MWZ

By decision year
1 clearance under product code MWZ with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MWZ by decision year
YearClearances
19771

Applicants with the most clearances

Product code MWZ
Applicants holding the most 510(k) clearances under product code MWZ
ApplicantClearances
Gamma Enterprises, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MWZ.