GrindCare System
K-Number: K163448 · 2017-09-01
ApplicantSunstar Suisse S.A.
Decision Date2017-09-01
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
GrindCare System is a medical device manufactured by Sunstar Suisse S.A.. It received FDA 510(k) clearance on 2017-09-01 under approval number K163448. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GrindCare System?
GrindCare System is a medical device that received FDA 510(k) clearance on 2017-09-01. It is manufactured by Sunstar Suisse S.A.. The 510(k) number is K163448.
When was GrindCare System approved by the FDA?
GrindCare System received FDA 510(k) clearance on 2017-09-01, under approval number K163448.
What company makes GrindCare System?
GrindCare System is manufactured by Sunstar Suisse S.A..
What is the FDA product code for GrindCare System?
The FDA product code for GrindCare System is HCC.
Related Devices (Code: HCC)
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.