PYO
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5240
- Medical specialty
- General Hospital
- FDA 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
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Zip 4 Skin Closure Device (K170003) | Zipline Medical, Inc. | 2017-08-18 |
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Every clearance here is in the API, with alerts when new ones post.