510(k) K253290
- Device
- XSTAT P15
- Applicant
- Revmedx, Inc.
- 510(k) number
- K253290
- Product code
- PGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-11-12
- Date received
- 2025-09-29
- Regulation
- 878.4452
- Classification name
- Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Amy K. Pointer
- Address
- 25749 S W Canyon Creek Rd. Suite 300 Wilsonville OR US 97070 97070
FDA Registration Numbers#
- 2029275
- 2953359
- 3009035955
Source Documents#
Other 510(k) Records For Product Code PGZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021-08-27 |
| K180051 | XSTAT 30, 1-Pack | Revmedx, Inc. | 2018-05-18 |
| K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | Revmedx, Inc. | 2017-05-01 |
| K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | Revmedx, Inc. | 2016-07-28 |
| K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK | Revmedx, Inc. | 2015-12-07 |
| DEN130016 | XSTAT | Revmedx, Inc. | 2014-04-03 |