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FDA 510(k)

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11

K-Number: K200841 · 2020-05-11

ApplicantEthicon Endo-Surgery, LLC
Decision Date2020-05-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 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 2020-05-11 under 510(k) number K200841. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is a medical device that received FDA 510(k) clearance on 2020-05-11. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K200841.

When did Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 receive FDA 510(k) clearance?

Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 received FDA 510(k) clearance on 2020-05-11, under 510(k) number K200841.

Who is the listed applicant for Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11?

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, 20cm length, Harmonic 1100 36cm length, Generator G11?

The FDA product code for Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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