DANNIK Disposable Monopolar Laparoscopic Instrument
K-Number: K193019 · 2020-03-04
ApplicantDannik
Decision Date2020-03-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DANNIK Disposable Monopolar Laparoscopic Instrument is a medical device manufactured by Dannik. It received FDA 510(k) clearance on 2020-03-04 under approval number K193019. 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 DANNIK Disposable Monopolar Laparoscopic Instrument?
DANNIK Disposable Monopolar Laparoscopic Instrument is a medical device that received FDA 510(k) clearance on 2020-03-04. It is manufactured by Dannik. The 510(k) number is K193019.
When was DANNIK Disposable Monopolar Laparoscopic Instrument approved by the FDA?
DANNIK Disposable Monopolar Laparoscopic Instrument received FDA 510(k) clearance on 2020-03-04, under approval number K193019.
What company makes DANNIK Disposable Monopolar Laparoscopic Instrument?
DANNIK Disposable Monopolar Laparoscopic Instrument is manufactured by Dannik.
What is the FDA product code for DANNIK Disposable Monopolar Laparoscopic Instrument?
The FDA product code for DANNIK Disposable Monopolar Laparoscopic Instrument is GEI.
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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.