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FDA 510(k)

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length

K-Number: K191555 · 2020-02-28

ApplicantEthicon Endo-Surgery, LLC
Decision Date2020-02-28
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length is a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2020-02-28 under approval number K191555. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length?

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K191555.

When was HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length approved by the FDA?

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length received FDA 510(k) clearance on 2020-02-28, under approval number K191555.

What company makes HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length?

HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length is manufactured by Ethicon Endo-Surgery, LLC.

What is the FDA product code for HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length?

The FDA product code for HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length is LFL.

Related Clinical Trials

NCT06608485 A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical Procedures RECRUITING

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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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