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FDA 510(k)

MAKO 7

K-Number: K182975 · 2019-05-21

ApplicantBoston Scientific Corporation
Decision Date2019-05-21
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MAKO 7 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-05-21 under 510(k) number K182975. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAKO 7?

MAKO 7 is a medical device that received FDA 510(k) clearance on 2019-05-21. The listed applicant is Boston Scientific Corporation. The 510(k) number is K182975.

When did MAKO 7 receive FDA 510(k) clearance?

MAKO 7 received FDA 510(k) clearance on 2019-05-21, under 510(k) number K182975.

Who is the listed applicant for MAKO 7?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAKO 7?

The FDA product code for MAKO 7 is HIH.

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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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