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FDA 510(k)

Monopolar Single Use Laparoscopic Instrument

K-Number: K171523 · 2017-08-22

ApplicantGetsch+Hiller Medizintechnik GmbH
Decision Date2017-08-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Monopolar Single Use Laparoscopic Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Getsch+Hiller Medizintechnik GmbH. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K171523. 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 Monopolar Single Use Laparoscopic Instrument?

Monopolar Single Use Laparoscopic Instrument is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Getsch+Hiller Medizintechnik GmbH. The 510(k) number is K171523.

When did Monopolar Single Use Laparoscopic Instrument receive FDA 510(k) clearance?

Monopolar Single Use Laparoscopic Instrument received FDA 510(k) clearance on 2017-08-22, under 510(k) number K171523.

Who is the listed applicant for Monopolar Single Use Laparoscopic Instrument?

The FDA 510(k) record lists Getsch+Hiller Medizintechnik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monopolar Single Use Laparoscopic Instrument?

The FDA product code for Monopolar Single Use Laparoscopic Instrument is GEI.

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Official Source

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

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