FDA Product Code
FDA Product Code PGZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4452
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253290 | XSTAT P15 | Revmedx, Inc. | 2025-11-12 | Traditional | PDF ↗ |
| K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021-08-27 | Traditional | PDF ↗ |
| K180051 | XSTAT 30, 1-Pack | Revmedx, Inc. | 2018-05-18 | Traditional | PDF ↗ |
| K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | Revmedx, Inc. | 2017-05-01 | Traditional | PDF ↗ |
| K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | Revmedx, Inc. | 2016-07-28 | Traditional | PDF ↗ |
| K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK | Revmedx, Inc. | 2015-12-07 | Traditional | PDF ↗ |
| DEN130016 | XSTAT | Revmedx, Inc. | 2014-04-03 | Direct | — |
Product code PGZ · Class II · General, Plastic Surgery. Data: openFDA.