Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Hot Biopsy Forceps

K-Number: K160625 · 2016-06-14

ApplicantMicro-Tech (Nanjing) Co., Ltd.
Decision Date2016-06-14
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Hot Biopsy Forceps is a medical device manufactured by Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2016-06-14 under approval number K160625. 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 2016-06-14. It is manufactured by Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K160625.

When was Disposable Hot Biopsy Forceps approved by the FDA?

Disposable Hot Biopsy Forceps received FDA 510(k) clearance on 2016-06-14, under approval number K160625.

What company makes Disposable Hot Biopsy Forceps?

Disposable Hot Biopsy Forceps is manufactured by Micro-Tech (Nanjing) Co., Ltd..

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

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

Related Clinical Trials

NCT06824402 Cryoprobe Biopsy and Chronic Rejection in Lung Transplant Recipients RECRUITING NCT05751278 Cryoprobe Versus Forceps for Transbronchial Biopsy COMPLETED

Other Devices by Micro-Tech (Nanjing) Co., Ltd.

K162466LuminScan (TM) Imaging System K152802Grasping Forceps K172309Endoscopic Ultrasound Aspiration Needle K162226Reliant Multistage Dilatation Balloon Catheter K161463SureClip(TM) Repositionable Hemostasis Clip K182556SureClip Repositionable Hemostasis Clip

View all 37 devices →

Related Devices (Code: KGE)

K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. K171916Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. K171096Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC

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.

↑