Arthrosteer Ablator & Coagulator, Models Ref 1070 & 1080

by Orthodynamix, LLC

510(k) K093086

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K093086↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK093086	Date23 Feb 2010Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K093086
FDA Product Code: GEI

Device Class: Class II
Regulation: 21 CFR Part 878.4400
Advisory Committee: General, Plastic Surgery
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arthrosteer Ablator & Coagulator (Models Ref 1070 & 1080) is an electrosurgical device designed for soft tissue management, classified under the General, Plastic Surgery advisory committee. It functions as an ablative and coagulative tool, enabling precise resection, ablation, excision of soft tissue, and hemostasis during surgical procedures.

Used in orthopedic and arthroscopic settings, this device is operated by surgeons in clinical or operating room environments. Supplied as a reusable medical instrument, it adheres to FDA 510(k) clearance (K093086) under Traditional review, with no specified sterility or MRI safety constraints in the provided data. The models are differentiated by their reference codes and intended for general surgical applications.