Cleared Special

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)

K232313 · Ethicon Endo-Surgery, LLC · General & Plastic Surgery
Aug 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K232313 is an FDA 510(k) clearance for the LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320), a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, PR). The FDA issued a Cleared decision on August 29, 2023, 27 days after receiving the submission on August 2, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K232313 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2023
Decision Date August 29, 2023
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FZP — Clip, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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