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FDA 510(k)

Disposable Hot Biopsy Forceps

K-Number: K180018 · 2018-07-05

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2018-07-05
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 Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2018-07-05 under 510(k) number K180018. 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 2018-07-05. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K180018.

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

Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2018-07-05, under 510(k) number K180018.

Who is the listed applicant for Disposable Hot Biopsy Forceps?

The FDA 510(k) record lists Micro-Tech (Nanjing) 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 Micro-Tech (Nanjing) Co., Ltd. as applicant

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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.K231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm CorporationK210406Bipolar Coagulation ForecepsHangzhou 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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