510(k) clearance
Cysto-Urethroscopes and accessories
- 510(k) number
- K260350
- Applicant
- Hangzhou Hawk Optical Electronic Instruments Co., Ltd.
- Decision date
- Oct 26, 2026
- Date received
- Feb 3, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FJL
- Device type
- Resectoscope
- Device class
- Class II
- Regulation
- 21 CFR 876.1500
- Advisory committee
- Gastroenterology, Urology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hangzhou, CN