Decision Date2022-03-30
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
BD Trek Powered Bone Biopsy System is a medical device manufactured by Bard Peripheral Vascular. It received FDA 510(k) clearance on 2022-03-30 under approval number K213896. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BD Trek Powered Bone Biopsy System?
BD Trek Powered Bone Biopsy System is a medical device that received FDA 510(k) clearance on 2022-03-30. It is manufactured by Bard Peripheral Vascular. The 510(k) number is K213896.
When was BD Trek Powered Bone Biopsy System approved by the FDA?
BD Trek Powered Bone Biopsy System received FDA 510(k) clearance on 2022-03-30, under approval number K213896.
What company makes BD Trek Powered Bone Biopsy System?
BD Trek Powered Bone Biopsy System is manufactured by Bard Peripheral Vascular.
What is the FDA product code for BD Trek Powered Bone Biopsy System?
The FDA product code for BD Trek Powered Bone Biopsy System is KNW.
Other Devices by Bard Peripheral Vascular
Related Devices (Code: KNW)
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K153709Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer StyletDevicor Medical Products, Inc.
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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.