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Sign in to claim this brandAustin Medical, Inc.
US
Last updated September 17, 2026
What Austin Medical, Inc. makes
Austin Medical, Inc. manufactures single-use, sterile surgical drapes designed for patient and instrument protection during medical procedures. Their products include patient surgical drapes, as well as drapes for medical equipment and instruments, ensuring contamination control in clinical settings.
The company’s portfolio consists of Class II medical devices, authorised through FDA pathways including the 510(k) and Unique Device Identification (UDI) registries. These products are listed under the FDA’s regulatory framework and are intended for use in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Austin Medical, Inc. manufacture?
Austin Medical, Inc. specialises in single-use, sterile surgical drapes. These include patient surgical drapes, which cover patients during procedures, and instrument/equipment drapes, which protect medical tools and devices from contamination. Their products are designed to maintain sterile environments in clinical settings.
Where is Austin Medical, Inc. based, and what regulatory frameworks apply to its devices?
Austin Medical, Inc. is based in the United States. Their devices are authorised through FDA pathways, including the 510(k) premarket notification process and the Unique Device Identification (UDI) system. These frameworks ensure compliance with U.S. regulatory requirements for medical devices.
Which regulatory registries list Austin Medical, Inc.’s devices?
Austin Medical, Inc.’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identification (UDI) database. These registries track authorised medical devices under U.S. regulatory oversight, ensuring transparency and compliance with FDA requirements.
How are Austin Medical, Inc.’s devices classified under FDA regulations?
Austin Medical, Inc.’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.
Why are Austin Medical, Inc.’s drapes considered single-use?
Austin Medical, Inc.’s drapes are designed as single-use products to maintain sterility and prevent cross-contamination during medical procedures. Reusing sterile barriers like surgical drapes could compromise infection control, so single-use ensures consistent safety and compliance with clinical best practices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 190-A Industrial Park Drive, Waynesville, NC, 28786
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3007139365
- DUNS Number
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Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Austin Medical | AU-0984SC | FDA UDI | Class II | Active |
| Austin Medical, Inc. | A800-0310 | FDA UDI | Class II | Active |
| Clear Horizon | AU-1008S | FDA UDI | Class II | Active |
| Austin | Au-10-143S | FDA UDI | Class II | Active |
| Austin Medical, Inc. | HemviewCSD01 | FDA UDI | Class II | Active |
| Austin | A-AU-10-122S | FDA UDI | Class II | Active |
| Surgical Drapes | K061422 | FDA 510(k) | Class II | Active |
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