510(k) clearance
Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
- 510(k) number
- K254294
- Applicant
- Zhejiang Geyi Medical Instrument Co., Ltd.
- Decision date
- Sep 8, 2026
- Date received
- Dec 31, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HIH
- Device type
- Hysteroscope (And Accessories)
- Device class
- Class II
- Regulation
- 21 CFR 884.1690
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Jiande City, CN