SLIMUS
K-Number: K192970 · 2020-12-01
ApplicantHironic Co., Ltd.
Decision Date2020-12-01
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SLIMUS is a medical device manufactured by Hironic Co., Ltd.. It received FDA 510(k) clearance on 2020-12-01 under approval number K192970. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SLIMUS?
SLIMUS is a medical device that received FDA 510(k) clearance on 2020-12-01. It is manufactured by Hironic Co., Ltd.. The 510(k) number is K192970.
When was SLIMUS approved by the FDA?
SLIMUS received FDA 510(k) clearance on 2020-12-01, under approval number K192970.
What company makes SLIMUS?
SLIMUS is manufactured by Hironic Co., Ltd..
What is the FDA product code for SLIMUS?
The FDA product code for SLIMUS is PKT.
Other Devices by Hironic Co., Ltd.
Related Devices (Code: PKT)
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.