PYO · Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
General Hospital · 21 CFR 880.5240 · Class 1
Overview
| Product Code | PYO |
|---|---|
| Device Name | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use |
| Regulation | 21 CFR 880.5240 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A medical adhesive tape or adhesive bandage is 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 Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170003 | Zip 4 Skin Closure Device | Zipline Medical, Inc. | Aug 18, 2017 | SESE |
Top Applicants
- Zipline Medical, Inc. — 1 clearance
