Clearance Summary
LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) received FDA 510(k) clearance under submission number K232313, sponsored by Ethicon Endo Surgery, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-08-29.
- Submission: K232313
- Applicant / Sponsor: Ethicon Endo Surgery, LLC
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4300
- Decision date: 2023-08-29
Classification & Regulation
This clearance is catalogued under FDA product code FZP and 21 CFR 878.4300, within the General, Plastic Surgery review panel as a Class II device.