510(k) K250643
K250643 is an FDA 510(k) premarket notification submitted by Hangzhou Kangji Medical Instrument Co., Ltd. for the device "Disposable Polymer Ligation Clips". The FDA issued a decision of Substantially Equivalent on November 20, 2025. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Hangzhou Kangji Medical Instrument Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 20, 2025
- Date Received
- March 4, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type