510(k) clearance
Single-use Flexible Bronchoscope
- 510(k) number
- K261637
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd.
- Decision date
- Sep 23, 2026
- Date received
- May 18, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- EOQ
- Device type
- Bronchoscope (Flexible Or Rigid)
- Device class
- Class II
- Regulation
- 21 CFR 874.4680
- Advisory committee
- Ear, Nose, Throat
- Statement or summary
- Summary
- Third party
- N
- Location
- Xiangtan, CN