PQI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Wound Retraction And Protection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4371
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.
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| Record | Firm | Date |
|---|---|---|
| CleanCision Wound Retraction and Protection System (K172132) | Prescient Surgical, Inc. | 2017-10-25 |
| CleanCisionTM Wound Retraction and Protection System (DEN150038) | Prescient Surgical | 2016-12-16 |
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Every clearance here is in the API, with alerts when new ones post.