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 a medical device manufactured by Hans Biomed Corporation. It received FDA 510(k) clearance on 2018-02-22 under approval 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. It is manufactured by Hans Biomed Corporation. The 510(k) number is K171568.
When was SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty approved by the FDA?
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty received FDA 510(k) clearance on 2018-02-22, under approval number K171568.
What company makes SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty?
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty is manufactured by Hans Biomed Corporation.
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 Devices by Hans Biomed Corporation
Related Devices (Code: MQV)
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.