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FDA 510(k)

CORE-SNARE

K-Number: K220846 · 2022-11-21

Decision Date2022-11-21
Product CodeFDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE-SNARE is the device name listed in this FDA 510(k) record. The listed applicant is Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K220846. The device is classified under product code FDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE-SNARE?

CORE-SNARE is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Incore Co., Ltd.. The 510(k) number is K220846.

When did CORE-SNARE receive FDA 510(k) clearance?

CORE-SNARE received FDA 510(k) clearance on 2022-11-21, under 510(k) number K220846.

Who is the listed applicant for CORE-SNARE?

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

What is the FDA product code for CORE-SNARE?

The FDA product code for CORE-SNARE is FDI.

Other records listing Incore 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.

Related Devices (Code: FDI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.