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FDA 510(k)

BioStamp nPoint

K-Number: K173510 · 2018-05-08

ApplicantMc10, Inc.
Decision Date2018-05-08
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BioStamp nPoint is a medical device manufactured by Mc10, Inc.. It received FDA 510(k) clearance on 2018-05-08 under approval number K173510. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioStamp nPoint?

BioStamp nPoint is a medical device that received FDA 510(k) clearance on 2018-05-08. It is manufactured by Mc10, Inc.. The 510(k) number is K173510.

When was BioStamp nPoint approved by the FDA?

BioStamp nPoint received FDA 510(k) clearance on 2018-05-08, under approval number K173510.

What company makes BioStamp nPoint?

BioStamp nPoint is manufactured by Mc10, Inc..

What is the FDA product code for BioStamp nPoint?

The FDA product code for BioStamp nPoint is DRG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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