510(k) K161600
K161600 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 September 6, 2016. The device falls under product code JOS (Electrode, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 6, 2016
- Date Received
- June 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type