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510(k) K242010

Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1) by Shenzhen Sanping Image Technology Co., Ltd. — Product Code EOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2025
Date Received
July 10, 2024
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).

Other clearances by Shenzhen Sanping Image Technology Co., Ltd.

  • K250917 — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: S (October 31, 2025)

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  • K252045 — Ion Endoluminal System (IF1000) (September 23, 2025)
  • K251894 — Himaging Bronchscope System (September 23, 2025)
  • K252528 — Ion Endoluminal System (IF1000) (September 5, 2025)
  • K251752 — Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (August 27, 2025)
  • K251823 — UE BRONCHO Single-Use Bronchoscopes (EBS-380C); UE BRONCHO Single-Use Bronchosco (August 11, 2025)
  • K250232 — Vathin® Video Bronchoscope System (July 25, 2025)
  • K250862 — EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEO (June 23, 2025)
  • K244017 — FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 (June 13, 2025)