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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2017-09-14 under 510(k) 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. The listed applicant is Medos International SARL. The 510(k) number is K170937.

When did VIPER PRIME navigated inserter receive FDA 510(k) clearance?

VIPER PRIME navigated inserter received FDA 510(k) clearance on 2017-09-14, under 510(k) number K170937.

Who is the listed applicant for VIPER PRIME navigated inserter?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

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.

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