FDA 510(k)

HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)

K番号: K254196 · 2026-09-17

決定日2026-09-17

製品コードGEI

諮問委員会SU

決定Substantially Equivalent

医療機器の概要

HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) 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 2026-09-17 under 510(k) number K254196. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)?

HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K254196.

When did HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) receive FDA 510(k) clearance?

HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) received FDA 510(k) clearance on 2026-09-17, under 510(k) number K254196.

Who is the listed applicant for HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)?

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 HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)?

The FDA product code for HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136) is GEI.

申請者としてEthicon Endo-Surgery, LLCを記載するその他の記録

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