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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 a medical device manufactured by Getsch+Hiller Medizintechnik GmbH. It received FDA 510(k) clearance on 2017-08-22 under approval 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. It is manufactured by Getsch+Hiller Medizintechnik GmbH. The 510(k) number is K171523.

When was Monopolar Single Use Laparoscopic Instrument approved by the FDA?

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

What company makes Monopolar Single Use Laparoscopic Instrument?

Monopolar Single Use Laparoscopic Instrument is manufactured by Getsch+Hiller Medizintechnik GmbH.

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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