510(k) DEN130016
- Device
- XSTAT
- Applicant
- Revmedx, Inc.
- 510(k) number
- DEN130016
- Product code
- PGZ
- Decision
- Unknown (DENG)
- Decision date
- 2014-04-03
- Date received
- 2013-01-30
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- JOHN J SMITH
- Address
- 555 13th St., NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3009035955
- 2953359
- 2029275
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| 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 |