FDA 510(k)

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

K-번호: K232313 · 2023-08-29

결정일2023-08-29

제품 코드FZP

자문 위원회SU

결정Substantially Equivalent

기기 요약

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo Surgery, LLC. It received FDA 510(k) clearance on 2023-08-29 under 510(k) number K232313. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

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

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) is a medical device that received FDA 510(k) clearance on 2023-08-29. The listed applicant is Ethicon Endo Surgery, LLC. The 510(k) number is K232313.

When did LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) receive FDA 510(k) clearance?

LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) received FDA 510(k) clearance on 2023-08-29, under 510(k) number K232313.

Who is the listed applicant for LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)?

The FDA 510(k) record lists Ethicon Endo Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)?

The FDA product code for LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) is FZP.

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