Reprocessed Soft Tissue Ablators
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012631 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Reprocessed Soft Tissue Ablators are devices intended to remove soft tissue and control bleeding by providing tissue ablation and coagulation utilizing high-frequency electrical current. They are used in patients requiring general or arthroscopic surgery.
These devices are supplied as reprocessed single-use devices and are indicated for use in arthroscopic surgery of the knee, shoulder, ankle, hip, wrist, and elbow. They were cleared via the FDA 510(k) pathway under K012631 with product code GEI and are manufactured by Alliance Medical Corp.
Frequently asked questions
What is the Reprocessed Soft Tissue Ablator used for?
It is intended to remove soft tissue and control bleeding by providing tissue ablation and coagulation using high-frequency electrical current during general or arthroscopic surgery.
How is the Reprocessed Soft Tissue Ablator supplied and intended for use?
It is supplied as a reprocessed single-use device and is indicated for arthroscopic surgery of the knee, shoulder, ankle, hip, wrist, and elbow.
What regulatory pathway was used for the Reprocessed Soft Tissue Ablator?
It was cleared via the FDA 510(k) pathway under K012631 with product code GEI, determined to be substantially equivalent to a predicate device.
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: REPROCESSED SOFT TISSUE ABLATORS (K012631) — FDA 510 (k) | Innolitics, REPROCESSED SOFT TISSUE ABLATORS 510(k) K012631 - FDA.report, PDF K012631 - Reprocessed Soft Tissue Ablators, REPROCESSED SOFT TISSUE ABLATORS (K012631) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012631 | Class II | Active |
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Manufacturer
- Manufacturer
- Alliance Medical, Inc.
- FDA Applicant
- Alliance Medical Corp.
Sources (1)
- FDA 510(k) K012631 24 fields · synced Sep 25, 2026