Bronchoscope System
FDA 510(k) K222910 · Shenzhen HugeMed Medical Technical Development Co., Ltd.
510(k) numberK222910
Submission
- Device name
- Bronchoscope System
- Applicant
- Shenzhen HugeMed Medical Technical Development Co., Ltd.
Shenzhen, CN - Received
- September 26, 2022
- Decision date
- April 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- Ear, Nose, Throat
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…
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| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | Intuitive Surgical, Inc. | 09/23/2025SE |
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Questions and answers
When was Bronchoscope System cleared by the FDA?
Bronchoscope System (K222910) received a 510(k) decision of Substantially Equivalent on April 11, 2023, 197 days after the submission was received.
What is the product code of K222910?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.