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

Instrument For Treatment Of Hyperhidrosis

21 CFR 878.4400 / General, Plastic Surgery
FDA source (opens on fda.gov)

OUB is the FDA product code for Instrument For Treatment Of Hyperhidrosis, a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "Soft-tissue coagulation". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
OUB
Device name
Instrument For Treatment Of Hyperhidrosis
FDA definition
Soft-tissue coagulation
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
2

Clearances, product code OUB

By decision year
3 clearances under product code OUB with a decision year between 2011 and 2015, 2011 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OUB by decision year
YearClearances
20111
20131
20151

Applicants with the most clearances

Product code OUB
Applicants holding the most 510(k) clearances under product code OUB
ApplicantClearances
miraDry, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code