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FDA 510(k)

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty

K-Number: K171568 · 2018-02-22

ApplicantHans Biomed Corporation
Decision Date2018-02-22
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty is the device name listed in this FDA 510(k) record. The listed applicant is Hans Biomed Corporation. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171568. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty?

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Hans Biomed Corporation. The 510(k) number is K171568.

When did SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty receive FDA 510(k) clearance?

SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171568.

Who is the listed applicant for SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty?

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

What is the FDA product code for SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty?

The FDA product code for SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty is MQV.

Other records listing Hans Biomed Corporation as applicant

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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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