510(k) K182876

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

July 2, 2019

Date Received

October 12, 2018

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Cystoscope And Accessories, Flexible/Rigid

Device Class

Class II

Regulation Number

876.1500

Review Panel

GU

Submission Type

To examine and perform procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).