Hysteroscopy System
FDA 510(k) clearance K172151 · decided 2018-04-09
Clearance details
- K-number
- K172151
- Device name
- Hysteroscopy System
- Applicant
- Chongquin Jinshan Science & Technology (Group) Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-07-17
- Decision date
- 2018-04-09
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- HGH
- Device class
- 2
- Regulation number
- 884.5070
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Chongqing, CN
- Third-party review
- No
- Expedited review
- No
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| RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) (K093508) | Womancare Global | 2010-03-04 |
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Recalls involving this device
No recalls on record reference this clearance.