510(k) K965118
K965118 is an FDA 510(k) premarket notification submitted by Endocare, Inc. for the device "ENDOCARE MONOPOLAR ELECTRODE". The FDA issued a decision of Substantially Equivalent on February 25, 1997. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Endocare, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1997
- Date Received
- December 20, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical, Active, Urological
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type