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FDA 510(k)

CORE-CLIP

K-Number: K213338 · 2022-06-23

ApplicantIncore Co., Ltd.
Decision Date2022-06-23
Product CodePKL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORE-CLIP is a medical device manufactured by Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-06-23 under approval number K213338. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE-CLIP?

CORE-CLIP is a medical device that received FDA 510(k) clearance on 2022-06-23. It is manufactured by Incore Co., Ltd.. The 510(k) number is K213338.

When was CORE-CLIP approved by the FDA?

CORE-CLIP received FDA 510(k) clearance on 2022-06-23, under approval number K213338.

What company makes CORE-CLIP?

CORE-CLIP is manufactured by Incore Co., Ltd..

What is the FDA product code for CORE-CLIP?

The FDA product code for CORE-CLIP is PKL.

Other Devices by Incore Co., Ltd.

K221054CORE-INJECTOR K220846CORE-SNARE K220081CORE-SPORT K211148CORE-Trocar K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)

Related Devices (Code: PKL)

K153550FTRD System SetOvesco Endoscopy AG K170867FTRD System SetOvesco Endoscopy AG K161463SureClip(TM) Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K182556SureClip Repositionable Hemostasis ClipMicro-Tech (Nanjing) Co., Ltd. K180325Single Use MultiClip DeviceMicro-Tech (Nanjing) Co., Ltd. K172727HemoclipHangzhou AGS MedTech Co., Ltd.

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.

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