PGZ
7 FDA 510(k) clearances · Product code
107 daysmedian time to decision
428 days90th percentile
7clearances measured
FDA profile
- Official device name
- Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4452
- Medical specialty
- General, Plastic Surgery
- FDA definition
- To control bleeding in junctional, non-compressible wounds until surgical care is acquired.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| XSTAT P15 (K253290) | Revmedx, Inc. | 2025-11-12 |
| XSTAT 30 Pouch (K210676) | Revmedx, Inc. | 2021-08-27 |
| XSTAT 30, 1-Pack (K180051) | Revmedx, Inc. | 2018-05-18 |
| XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack (K170334) | Revmedx, Inc. | 2017-05-01 |
| XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (K161020) | Revmedx, Inc. | 2016-07-28 |
| XSTAT 30, 3-PACK, XSTAT 30, 1-PACK (K152624) | Revmedx, Inc. | 2015-12-07 |
| XSTAT (DEN130016) | Revmedx, Inc. | 2014-04-03 |
Track PGZ automatically
Every clearance here is in the API, with alerts when new ones post.