510(k) K060232

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 12, 2006

Date Received

January 30, 2006

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).