FDA 510(k)

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

K-Nummer: K200841 · 2020-05-11

Entscheidungsdatum2020-05-11

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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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Verwandte Geräte (Code: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

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