PGZ
- Product code
- PGZ
- Device name
- Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4452
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
FDA classification definition
To control bleeding in junctional, non-compressible wounds until surgical care is acquired.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253290 | 2025-11-12 | Revmedx, Inc. | XSTAT P15 |
Official FDA classification page: PGZ
Classification and pathway per current FDA publications. Data from openFDA (CC0).