Laparoscope Lens Shield Device
K-Number: K160172 · 2016-04-21
ApplicantMedeon Biodesign, Inc.
Decision Date2016-04-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Laparoscope Lens Shield Device is a medical device manufactured by Medeon Biodesign, Inc.. It received FDA 510(k) clearance on 2016-04-21 under approval number K160172. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Laparoscope Lens Shield Device?
Laparoscope Lens Shield Device is a medical device that received FDA 510(k) clearance on 2016-04-21. It is manufactured by Medeon Biodesign, Inc.. The 510(k) number is K160172.
When was Laparoscope Lens Shield Device approved by the FDA?
Laparoscope Lens Shield Device received FDA 510(k) clearance on 2016-04-21, under approval number K160172.
What company makes Laparoscope Lens Shield Device?
Laparoscope Lens Shield Device is manufactured by Medeon Biodesign, Inc..
What is the FDA product code for Laparoscope Lens Shield Device?
The FDA product code for Laparoscope Lens Shield Device is GCJ.
Related Clinical Trials
Other Devices by Medeon Biodesign, Inc.
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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.