Restrata®
K-Number: K193583 · 2020-09-25
ApplicantAcera Surgical, Inc.
Decision Date2020-09-25
Product CodeQSZ
DecisionSubstantially Equivalent
Device Summary
Restrata® is a medical device manufactured by Acera Surgical, Inc.. It received FDA 510(k) clearance on 2020-09-25 under approval number K193583. The device is classified under product code QSZ. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Restrata®?
Restrata® is a medical device that received FDA 510(k) clearance on 2020-09-25. It is manufactured by Acera Surgical, Inc.. The 510(k) number is K193583.
When was Restrata® approved by the FDA?
Restrata® received FDA 510(k) clearance on 2020-09-25, under approval number K193583.
What company makes Restrata®?
Restrata® is manufactured by Acera Surgical, Inc..
What is the FDA product code for Restrata®?
The FDA product code for Restrata® is QSZ.
Other Devices by Acera Surgical, Inc.
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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.