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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 the device name listed in this FDA 510(k) record. The listed applicant is Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-06-23 under 510(k) 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. The listed applicant is Incore Co., Ltd.. The 510(k) number is K213338.

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

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

Who is the listed applicant for CORE-CLIP?

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-CLIP?

The FDA product code for CORE-CLIP is PKL.

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)K221054CORE-INJECTORK220846CORE-SNAREK220081CORE-SPORTK211148CORE-Trocar

Related Devices (Code: PKL)

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.

K254069Hemoclip (511 series, 543 series)Hangzhou AGS MedTech Co., Ltd.K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus ClipTaurus EndoscopyK251562OTSCneo System Set (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AGK252271HemoclipHangzhou 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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