Video Bronchoscope System +2 more— 510(k) K241612
Substantially EquivalentHunan Vathin Medical Instrument Co., Ltd.
FDA 510(k) clearance K241612 for Video Bronchoscope System +2 more, Substantially Equivalent on 2024-10-29. Applicant: Hunan Vathin Medical Instrument Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- 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.
- Product code
- Code EOQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Xiangtan, CN
Recent devices under product code EOQ
view allMore clearances from Hunan Vathin Medical Instrument Co., Ltd.
view all- K250232 — Vathin® Video Bronchoscope System
- K251599 — Single-use Ureteral Access Sheath
- K250785 — Single-use Flexible Ureteroscope
- K243117 — Digital Video Processor
- K242416 — Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12 +2 more
Adverse events under product code EOQ
product code EOQ- Death
- 135
- Injury
- 2,863
- Malfunction
- 21,662
- Total
- 24,660
Source: openFDA MAUDE database, through . 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.