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)

Plasonic (Plasonic)

K-Number: K241099 · 2024-11-08

ApplicantHironic Co., Ltd.
Decision Date2024-11-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Plasonic (Plasonic) is a medical device manufactured by Hironic Co., Ltd.. It received FDA 510(k) clearance on 2024-11-08 under approval number K241099. 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 Plasonic (Plasonic)?

Plasonic (Plasonic) is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Hironic Co., Ltd.. The 510(k) number is K241099.

When was Plasonic (Plasonic) approved by the FDA?

Plasonic (Plasonic) received FDA 510(k) clearance on 2024-11-08, under approval number K241099.

What company makes Plasonic (Plasonic)?

Plasonic (Plasonic) is manufactured by Hironic Co., Ltd..

What is the FDA product code for Plasonic (Plasonic)?

The FDA product code for Plasonic (Plasonic) is GEI.

Other Devices by Hironic Co., Ltd.

K173676A-FIT K192970SLIMUS K201773PICOHI K210084SILKRO 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.

↑