510(k) K213354
K213354 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart". The FDA issued a decision of Substantially Equivalent on March 11, 2022. The device falls under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories), a Class II device regulated under 21 CFR 878.4400. Conmed Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 2022
- Date Received
- October 12, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrosurgical, Cutting & Coagulation & Accessories
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).