510(k) K141366

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

December 17, 2014

Date Received

May 23, 2014

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Bronchoscope (Flexible Or Rigid)

Device Class

Class II

Regulation Number

874.4680

Review Panel

EN

Submission Type

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the device is reprocessed, reprocessing validation data for this device type must be included in a 510(k) submission. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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).