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

FDA 510(k)

SILKRO

K-Number: K210084 · 2022-06-03

ApplicantHironic Co., Ltd.
Decision Date2022-06-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILKRO is a medical device manufactured by Hironic Co., Ltd.. It received FDA 510(k) clearance on 2022-06-03 under approval number K210084. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILKRO?

SILKRO is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Hironic Co., Ltd.. The 510(k) number is K210084.

When was SILKRO approved by the FDA?

SILKRO received FDA 510(k) clearance on 2022-06-03, under approval number K210084.

What company makes SILKRO?

SILKRO is manufactured by Hironic Co., Ltd..

What is the FDA product code for SILKRO?

The FDA product code for SILKRO is GEI.

Other Devices by Hironic Co., Ltd.

K173676A-FIT K192970SLIMUS K201773PICOHI K241099Plasonic (Plasonic) K233123SILKRO K251334NEW DOUBLO 2.0

View all 8 devices →

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑