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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 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 2020-02-28 under 510(k) 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. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K191555.

When did HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length receive FDA 510(k) clearance?

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

Who is the listed applicant for HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length?

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 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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06608485A Study of HARMONIC 700 Shears With Advanced Hemostasis in Pediatric and Adult Surgical ProceduresCOMPLETEDNCT04253392RETHINK REFLUX RegistryACTIVE_NOT_RECRUITINGNCT07744568A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic ProceduresNOT_YET_RECRUITING

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Related Devices (Code: LFL)

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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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