Endocare Monopolar Electrode
FDA 510(k) K965118 · Endocare, Inc.
510(k) numberK965118
Submission
- Device name
- Endocare Monopolar Electrode
- Applicant
- Endocare, Inc.
Irvine, CA, US - Received
- December 20, 1996
- Decision date
- February 25, 1997
- 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 Endocare Monopolar Electrode cleared by the FDA?
Endocare Monopolar Electrode (K965118) received a 510(k) decision of Substantially Equivalent on February 25, 1997, 67 days after the submission was received.
What is the product code of K965118?
The FDA product code is FAS – Electrode, Electrosurgical, Active, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.4300.