FDA product code OUB: Instrument For Treatment Of Hyperhidrosis
OUB is the FDA product code for instrument for treatment of hyperhidrosis. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under OUB. The average 510(k) review took 137 days (median 121). FDA has posted 2 recalls for OUB devices.
Definition
Soft-tissue coagulation
Classification
| Field | Value |
|---|---|
| Device name | Instrument For Treatment Of Hyperhidrosis |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every OUB clearance
Top OUB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miramar Labs, Inc. | 3 | 2015-06-19 |
Most recent OUB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150419 | Miramar Labs, Inc. | miraDry System MD4000 | 2015-06-19 | 121 |
| K131162 | Miramar Labs, Inc. | MIRADRY SYSTEM | 2013-10-25 | 184 |
| K103014 | Miramar Labs, Inc. | MIRADRY SYSTEM | 2011-01-28 | 107 |
Recalls for OUB devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-09.
Frequently asked questions
What is FDA product code OUB?
OUB is the FDA product code for instrument for treatment of hyperhidrosis. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is OUB?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OUB?
Across 3 cleared submissions the average was 137 days from receipt to decision (median 121).
Which companies have the most OUB clearances?
Miramar Labs, Inc. (3).
Have OUB devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2015-10-09.
Next steps
- Run an FDA pathway report with predicate devices for product code OUB
- Run a recall and safety report across every OUB manufacturer
- Watch product code OUB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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