Arthrocare Bipolar Electrosurgery System
FDA 510(k) K031029 · Arthrocare Corp.
510(k) numberK031029
Submission
- Device name
- Arthrocare Bipolar Electrosurgery System
- Applicant
- Arthrocare Corp.
Sunnyvale, CA, US - Received
- April 1, 2003
- Decision date
- June 19, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FAS – Electrode, Electrosurgical, Active, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4300
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Arthrocare Bipolar Electrosurgery System cleared by the FDA?
Arthrocare Bipolar Electrosurgery System (K031029) received a 510(k) decision of Substantially Equivalent on June 19, 2003, 79 days after the submission was received.
What is the product code of K031029?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.