Ligation Device
FDA 510(k) clearance K172985 · decided 2018-06-14
Clearance details
- K-number
- K172985
- Device name
- Ligation Device
- Applicant
- Leo Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2017-09-27
- Decision date
- 2018-06-14
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- FHN
- Device class
- 2
- Regulation number
- 876.4400
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Changzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.