Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03
FDA 510(k) K020579 · Aaron Medical Industries
510(k) numberK020579
Submission
- Device name
- Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03
- Applicant
- Aaron Medical Industries
St. Petersburg, FL, US - Received
- February 21, 2002
- Decision date
- May 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03 cleared by the FDA?
Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03 (K020579) received a 510(k) decision of Substantially Equivalent on May 13, 2002, 81 days after the submission was received.
What is the product code of K020579?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.