Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
The Non-Absorbable, Expandable, Hemostatic Sponge for Temporary Internal Use is a surgical hemostasis device designed to control bleeding in junctional and non-compressible wounds until definitive surgical care can be obtained. It is an FDA Class 2 device regulated under 21 CFR 878.4452, requiring 510(k) premarket notification, within the General and Plastic Surgery (SU) medical specialty. The product code is PGZ. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PGZ
- Device Class
- FDA class 2
- Regulation Number
- 878.4452
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
To control bleeding in junctional, non-compressible wounds until surgical care is acquired.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253290 | XSTAT P15 | Nov 12, 2025 | Substantially Equivalent | Revmedx, Inc. |
| K210676 | XSTAT 30 Pouch | Aug 27, 2021 | Substantially Equivalent | Revmedx, Inc. |
| K180051 | XSTAT 30, 1-Pack | May 18, 2018 | Substantially Equivalent | Revmedx, Inc. |
| K170334 | XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack | May 01, 2017 | Substantially Equivalent | Revmedx, Inc. |
| K161020 | XSTAT-12, 3-Pack, XSTAT-12, 1-Pack | Jul 28, 2016 | Substantially Equivalent | Revmedx, Inc. |
| K152624 | XSTAT 30, 3-PACK, XSTAT 30, 1-PACK | Dec 07, 2015 | Substantially Equivalent | Revmedx, Inc. |
| DEN130016 | XSTAT | Apr 03, 2014 | Unknown | Revmedx, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.