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FDA 510(k)

CORE-INJECTOR

K-Number: K221054 · 2022-12-21

ApplicantIncore Co., Ltd.
Decision Date2022-12-21
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE-INJECTOR 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 2022-12-21 under 510(k) number K221054. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE-INJECTOR?

CORE-INJECTOR is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Incore Co., Ltd.. The 510(k) number is K221054.

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

CORE-INJECTOR received FDA 510(k) clearance on 2022-12-21, under 510(k) number K221054.

Who is the listed applicant for CORE-INJECTOR?

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-INJECTOR?

The FDA product code for CORE-INJECTOR is FBK.

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.

K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)K220846CORE-SNAREK220081CORE-SPORTK213338CORE-CLIPK211148CORE-Trocar

Related Devices (Code: FBK)

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.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

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.

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