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FDA 510(k)

HEALIX ADVANCE KNOTLESS BR Anchor

K-Number: K180101 · 2018-05-10

ApplicantMedos International SARL
Decision Date2018-05-10
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEALIX ADVANCE KNOTLESS BR Anchor 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 2018-05-10 under 510(k) number K180101. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEALIX ADVANCE KNOTLESS BR Anchor?

HEALIX ADVANCE KNOTLESS BR Anchor is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is Medos International SARL. The 510(k) number is K180101.

When did HEALIX ADVANCE KNOTLESS BR Anchor receive FDA 510(k) clearance?

HEALIX ADVANCE KNOTLESS BR Anchor received FDA 510(k) clearance on 2018-05-10, under 510(k) number K180101.

Who is the listed applicant for HEALIX ADVANCE KNOTLESS BR Anchor?

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 HEALIX ADVANCE KNOTLESS BR Anchor?

The FDA product code for HEALIX ADVANCE KNOTLESS BR Anchor is MAI.

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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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