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FDA 510(k)

Disposable Hot Biopsy Forceps

K-Number: K231721 · 2023-12-14

ApplicantBeijing Zksk Technology Co., Ltd.
Decision Date2023-12-14
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hot Biopsy Forceps is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K231721. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Hot Biopsy Forceps?

Disposable Hot Biopsy Forceps is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Beijing Zksk Technology Co., Ltd.. The 510(k) number is K231721.

When did Disposable Hot Biopsy Forceps receive FDA 510(k) clearance?

Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2023-12-14, under 510(k) number K231721.

Who is the listed applicant for Disposable Hot Biopsy Forceps?

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

What is the FDA product code for Disposable Hot Biopsy Forceps?

The FDA product code for Disposable Hot Biopsy Forceps is KGE.

Other records listing Beijing Zksk Technology 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.

K242192Disposable SphincterotomeK213217Disposable hemoclipK213223Multi-Band LigatorK213222Disposable Polypectomy SnareK213239Endoscopic Injection Needle

Related Devices (Code: KGE)

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.

K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems CorporationK242857ClearHemograsperFinemedix Co., Ltd.K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm CorporationK210406Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) 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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