Bronchoscope System— 510(k) K222910

Name: FDA 510(k) clearance K222910
Creator: U.S. Food and Drug Administration
Published: 2023-04-11

Substantially Equivalent

Shenzhen HugeMed Medical Technical Development Co., Ltd.

FDA 510(k) clearance K222910 for Bronchoscope System, Substantially Equivalent on 2023-04-11. Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen HugeMed Medical Technical Development Co., Ltd.
Product code: Code EOQ
Device class: Class 2
Regulation: 21 CFR 874.4680
Advisory panel: Ear, Nose, Throat
Date received: 2022-09-26
Decision date: 2023-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code EOQ

view all

K260382 — MONARCH Platform (MON-000008)2026-07-25
K254037 — LungFlow Airway Catheter2026-07-10
K253137 — FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T2026-06-16
K260565 — SmartClip Delivery Catheter (ADR-1715)2026-05-14
K252341 — EVIS EXERA III BRONCHOVIDEOSCOPE (3 models)2026-04-23

More clearances from Shenzhen HugeMed Medical Technical Development Co., Ltd.

view all

K260892 — Suction Pump (SU-90)2026-05-14
K250695 — Single-use Ureteral Access Sheath2025-07-08
K241444 — Biliary Pancreaticobiliary Scope System2025-01-21
K240374 — Ureterorenoscope System2024-05-10
K232435 — Rhinolaryngoscope system2024-04-26

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.