510(k) clearance
Single-Use EBUS Balloon
- 510(k) number
- K261616
- Applicant
- Micro-Tech (Nanjing) Co., Ltd.
- Decision date
- Oct 15, 2026
- Date received
- May 15, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PSV
- Device type
- Ultrasound Bronchoscope
- Device class
- Class II
- Regulation
- 21 CFR 892.1550
- Advisory committee
- Radiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Nanjing, CN