Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
FDA 510(k) K241612 · Hunan Vathin Medical Instrument Co., Ltd.
Submission
- Device name
- Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
Xiangtan, CN - Received
- June 5, 2024
- Decision date
- October 29, 2024
- 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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More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250232 | Vathin® Video Bronchoscope SystemEOQ · Traditional | 07/25/2025SE |
| K251599 | Single-use Ureteral Access SheathFED · Special | 07/03/2025SE |
| K250785 | Single-use Flexible UreteroscopeFGB · Traditional | 05/06/2025SE |
| K243117 | Digital Video ProcessorFGB · Traditional | 01/29/2025SE |
| K242416 | Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11…EOQ · Traditional | 01/16/2025SE |
| K242535 | Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…FAJ · Traditional | 12/18/2024SE |
| K240167 | Single-use Ureteral Access SheathFED · Traditional | 10/08/2024SE |
| K241434 | Video Ureteroscope SystemFGB · Special | 10/04/2024SE |
| K231135 | Video Ureteroscope SystemFGB · Traditional | 01/17/2024SE |
| K230536 | Single-use Flexible Rhinolaryngoscope; Digital Video MonitorEOB · Traditional | 06/14/2023SE |
Questions and answers
When was Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) cleared by the FDA?
Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) (K241612) received a 510(k) decision of Substantially Equivalent on October 29, 2024, 146 days after the submission was received.
What is the product code of K241612?
The FDA product code is EOQ – Bronchoscope (Flexible Or Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.