FDA 510(k)

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider

K-Nummer: K161804 · 2016-09-16

AntragstellerCovidien

Entscheidungsdatum2016-09-16

ProduktcodeGEI

BeratungsausschussSU

EntscheidungSubstantially Equivalent

Produktübersicht

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K161804. 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 LigaSure Retractable L-Hook Laparoscopic Sealer/Divider?

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Covidien. The 510(k) number is K161804.

When did LigaSure Retractable L-Hook Laparoscopic Sealer/Divider receive FDA 510(k) clearance?

LigaSure Retractable L-Hook Laparoscopic Sealer/Divider received FDA 510(k) clearance on 2016-09-16, under 510(k) number K161804.

Who is the listed applicant for LigaSure Retractable L-Hook Laparoscopic Sealer/Divider?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LigaSure Retractable L-Hook Laparoscopic Sealer/Divider?

The FDA product code for LigaSure Retractable L-Hook Laparoscopic Sealer/Divider is GEI.

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Offizielle Quelle

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