VIPER PRIME navigated inserter
K-Number: K170937 · 2017-09-14
ApplicantMedos International SARL
Decision Date2017-09-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
VIPER PRIME navigated inserter is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2017-09-14 under approval number K170937. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VIPER PRIME navigated inserter?
VIPER PRIME navigated inserter is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Medos International SARL. The 510(k) number is K170937.
When was VIPER PRIME navigated inserter approved by the FDA?
VIPER PRIME navigated inserter received FDA 510(k) clearance on 2017-09-14, under approval number K170937.
What company makes VIPER PRIME navigated inserter?
VIPER PRIME navigated inserter is manufactured by Medos International SARL.
What is the FDA product code for VIPER PRIME navigated inserter?
The FDA product code for VIPER PRIME navigated inserter is OLO.
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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.