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FDA 510(k)

SILKRO

K-Number: K233123 · 2024-06-24

Decision Date2024-06-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILKRO is the device name listed in this FDA 510(k) record. The listed applicant is Hironic Co., Ltd.. It received FDA 510(k) clearance on 2024-06-24 under 510(k) number K233123. 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 2024-06-24. The listed applicant is Hironic Co., Ltd.. The 510(k) number is K233123.

When did SILKRO receive FDA 510(k) clearance?

SILKRO received FDA 510(k) clearance on 2024-06-24, under 510(k) number K233123.

Who is the listed applicant for SILKRO?

The FDA 510(k) record lists Hironic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILKRO?

The FDA product code for SILKRO is GEI.

Other records listing Hironic Co., Ltd. as applicant

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.

View all 8 devices →

Related Devices (Code: GEI)

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.

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.