510(k) K942597

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 15, 1994

Date Received

June 1, 1994

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Laparoscope, General & Plastic Surgery

Device Class

Class II

Regulation Number

876.1500

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).