510(k) K181982

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 21, 2018

Date Received

July 25, 2018

Clearance Type

Traditional

Expedited Review

No

Third Party Review

Yes

Device Classification

Device Name

Arthroscope

Device Class

Class II

Regulation Number

888.1100

Review Panel

OR

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).