Identifiers
- 510(k) Number
- K180051 FDA 510(k)
- FDA Product Code
- PGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4452 FDA 510(k)
- Regulation Number
- 878.4452 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The XSTAT 30, 1-Pack is a non-absorbable, expandable hemostatic sponge for temporary internal use, designed to control severe junctional bleeding in wounds where tourniquets cannot be applied, such as the groin, axilla, shoulder, or neck. It consists of compressed mini-sponges that expand upon contact with blood to rapidly form a mechanical clot. The device is intended for use in emergency and tactical settings to address life-threatening hemorrhage from penetrating trauma.
The XSTAT 30 is supplied as a single-use, sterile applicator containing dozens of X-ray detectable mini-sponges, each marked for radiographic visibility to aid in confirming complete removal. It is packaged in a compact, lightweight configuration for ease of transport and deployment. The device is regulated under FDA 510(k) clearance (K180051) as a Class II medical device, with a product code of PGZ and applicable regulation number 878.4452. It is not intended for reuse and should be stored in a dry, cool environment prior to use.
Frequently asked questions
What is the XSTAT 30 used for?
The XSTAT 30 is a non-absorbable, expandable hemostatic sponge designed to control severe junctional bleeding in wounds where tourniquets cannot be applied, such as the groin, axilla, shoulder, or neck. It is intended for use in emergency and tactical settings to address life-threatening hemorrhage from penetrating trauma.
How is the XSTAT 30 supplied?
The XSTAT 30 is supplied as a single-use, sterile applicator containing dozens of X-ray detectable mini-sponges. It is packaged in a compact, lightweight configuration for ease of transport and deployment.
Is the XSTAT 30 sterile and single-use?
Yes, the XSTAT 30 is supplied as a single-use, sterile applicator. It is not intended for reuse and should be discarded after a single application.
How should the XSTAT 30 be stored?
The XSTAT 30 should be stored in a dry, cool environment prior to use to maintain its integrity and sterility until the time of application.
What is the regulatory status of the XSTAT 30?
The XSTAT 30 is regulated under FDA 510(k) clearance (K180051) as a Class II medical device. It has a product code of PGZ and is subject to regulation number 878.4452.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: XSTAT P30 Hemostatic Device for Junctional Wounds - RevMedX, RevMedX X-STAT - Rapid Resource Medical Group, XSTAT Hemostatic Devices - RevMedX
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180051 | Class II | Active |
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Manufacturer
- Manufacturer
- Revmedx, Inc.
Sources (1)
- FDA 510(k) K180051 24 fields · synced Oct 6, 2026