Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Sunstar Suisse S.A.. It received FDA 510(k) clearance on 2017-09-01 under 510(k) 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. The listed applicant is Sunstar Suisse S.A.. The 510(k) number is K163448.

When did GrindCare System receive FDA 510(k) clearance?

GrindCare System received FDA 510(k) clearance on 2017-09-01, under 510(k) number K163448.

Who is the listed applicant for GrindCare System?

The FDA 510(k) record lists Sunstar Suisse S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GrindCare System?

The FDA product code for GrindCare System is HCC.

Related Devices (Code: HCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.

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.

↑