510(k) K180051
- Device
- XSTAT 30, 1-Pack
- Applicant
- RevMedx, Inc.
- 510(k) number
- K180051
- Product code
- PGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-05-18
- Date received
- 2018-01-08
- 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
- No
Applicant Contact#
- Contact
- Amy K. Pointer
- Address
- 25999 SW Canyon Creek Rd. Suite C Wilsonville, OR US 97070 97070
FDA Registration Numbers#
- 3009035955
- 2953359
- 2029275
Source Documents#
Other 510(k) Records For Product Code PGZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253290 | XSTAT P15 | Revmedx, Inc. | 2025-11-12 |
| K210676 | XSTAT 30 Pouch | Revmedx, Inc. | 2021-08-27 |
| 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 |
Legacy Summary#
summary
FDA Review#
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