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 Coaxial Biopsy Needle

K-Number: K212822 · 2022-07-06

ApplicantSuzhou Leapmed Healthcare Corporation
Decision Date2022-07-06
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Coaxial Biopsy Needle is a medical device manufactured by Suzhou Leapmed Healthcare Corporation. It received FDA 510(k) clearance on 2022-07-06 under approval number K212822. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Coaxial Biopsy Needle?

Disposable Coaxial Biopsy Needle is a medical device that received FDA 510(k) clearance on 2022-07-06. It is manufactured by Suzhou Leapmed Healthcare Corporation. The 510(k) number is K212822.

When was Disposable Coaxial Biopsy Needle approved by the FDA?

Disposable Coaxial Biopsy Needle received FDA 510(k) clearance on 2022-07-06, under approval number K212822.

What company makes Disposable Coaxial Biopsy Needle?

Disposable Coaxial Biopsy Needle is manufactured by Suzhou Leapmed Healthcare Corporation.

What is the FDA product code for Disposable Coaxial Biopsy Needle?

The FDA product code for Disposable Coaxial Biopsy Needle is FCG.

Related Clinical Trials

NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT00102544 Use of Tracking Devices to Locate Abnormalities During Invasive Procedures ENROLLING_BY_INVITATION NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION NCT05465161 STING MARK Universal Fiducial Marker System RECRUITING

Other Devices by Suzhou Leapmed Healthcare Corporation

K212284Disposable Automatic Core Biopsy Instrument K212819Disposable Biopsy Refill Needle K212820Disposable Semi Automatic Biopsy Instrument

Related Devices (Code: FCG)

K160423Perineologic Access NeedleCorbin Clinical Resources, LLC K160098Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp. K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland, Ltd. K171956Sterile Endoscope Biopsy Sampling NeedleChangzhou Detain Medical Devices Co., Ltd. K171596ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound NeedleWilson-Cook Medical, Inc. K160890Howell Biliary Introducer NeedleWilson-Cook Medical, Inc.

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.

↑