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FDA 510(k)

VIPER PRIME™ additions to the VIPER® System

K-Number: K162912 · 2016-12-08

ApplicantMedos International SARL
Decision Date2016-12-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VIPER PRIME™ additions to the VIPER® System 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 2016-12-08 under 510(k) number K162912. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIPER PRIME™ additions to the VIPER® System?

VIPER PRIME™ additions to the VIPER® System is a medical device that received FDA 510(k) clearance on 2016-12-08. The listed applicant is Medos International SARL. The 510(k) number is K162912.

When did VIPER PRIME™ additions to the VIPER® System receive FDA 510(k) clearance?

VIPER PRIME™ additions to the VIPER® System received FDA 510(k) clearance on 2016-12-08, under 510(k) number K162912.

Who is the listed applicant for VIPER PRIME™ additions to the VIPER® System?

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™ additions to the VIPER® System?

The FDA product code for VIPER PRIME™ additions to the VIPER® System is NKB.

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Related Devices (Code: NKB)

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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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