Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands
FDA 510(k) K020621 · Arthrocare Corp.
510(k) numberK020621
Submission
- Device name
- Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands
- Applicant
- Arthrocare Corp.
Sunnyvale, CA, US - Received
- February 26, 2002
- Decision date
- March 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands cleared by the FDA?
Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands (K020621) received a 510(k) decision of Substantially Equivalent on March 28, 2002, 30 days after the submission was received.
What is the product code of K020621?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.