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510(k) K251894

Himaging Bronchscope System by Himaging Technology (Shanghai) Co., Ltd. — Product Code EOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2025
Date Received
June 20, 2025
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).

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