510(k) K152092
K152092 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "Resection Electrodes". The FDA issued a decision of Substantially Equivalent on October 26, 2015. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2015
- Date Received
- July 28, 2015
- 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