FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
XSTAT P15
K Number: K253290
·
Decision Nov 12, 2025
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
7
Review Days
44
Basic Information
- Device Name
- XSTAT P15
- K Number
- K253290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4452
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Revmedx, Inc.
- Date Received
- September 29, 2025
- Decision Date
- November 12, 2025
- Product Code
- PGZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PGZ | Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PGZ), ordered by most recent decision date.
XSTAT 30 Pouch
FDA 510(k)
FDA Class 2
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XSTAT 30, 1-Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XSTAT 30, 3-PACK, XSTAT 30, 1-PACK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XSTAT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Revmedx, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K210676 | XSTAT 30 Pouch | Aug 27, 2021 | Substantially Equivalent |
| K180051 | XSTAT 30, 1-Pack | May 18, 2018 | Substantially Equivalent |
| K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | May 1, 2017 | Substantially Equivalent |
| K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | Jul 28, 2016 | Substantially Equivalent |
| K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK | Dec 7, 2015 | Substantially Equivalent |
| DEN130016 | XSTAT | Apr 3, 2014 | Unknown |