FDA product code PYO: Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
PYO is the FDA product code for tape and bandage, adhesive, adjustable closing mechanism, otc use. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under PYO. The average 510(k) review took 227 days (median 227).
Definition
A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin
Classification
| Field | Value |
|---|---|
| Device name | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use |
| Device class | Class I |
| Regulation | 21 CFR 880.5240 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PYO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 227 |
Compare with all 510(k) review times · Search every PYO clearance
Top PYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zipline Medical, Inc. | 1 | 2017-08-18 |
Most recent PYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170003 | Zipline Medical, Inc. | Zip 4 Skin Closure Device | 2017-08-18 | 227 |
Recalls for PYO devices
openFDA lists no recalls for product code PYO.
Frequently asked questions
What is FDA product code PYO?
PYO is the FDA product code for tape and bandage, adhesive, adjustable closing mechanism, otc use. It is a Class I device, regulated under 21 CFR 880.5240 and reviewed by the General and Plastic Surgery panel.
What device class is PYO?
Class I, regulation 21 CFR 880.5240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PYO?
Across 1 cleared submissions the average was 227 days from receipt to decision (median 227).
Which companies have the most PYO clearances?
Zipline Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PYO
- Run a recall and safety report across every PYO manufacturer
- Watch product code PYO 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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