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FDA 510(k)

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM

K-Number: K233294 · 2024-06-18

ApplicantItp Innovative Tomography Products GmbH
Decision Date2024-06-18
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is a medical device manufactured by Itp Innovative Tomography Products GmbH. It received FDA 510(k) clearance on 2024-06-18 under approval number K233294. 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 Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is a medical device that received FDA 510(k) clearance on 2024-06-18. It is manufactured by Itp Innovative Tomography Products GmbH. The 510(k) number is K233294.

When was Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM approved by the FDA?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM received FDA 510(k) clearance on 2024-06-18, under approval number K233294.

What company makes Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is manufactured by Itp Innovative Tomography Products GmbH.

What is the FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

The FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is KNW.

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Other Devices by Itp Innovative Tomography Products GmbH

K222462Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)

Related Devices (Code: KNW)

K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer NeedlesM.D.L. S.R.L. 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. K161234CASSI II Rotational Core Biopsy SystemScion Medical Technologies, LLC K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S K161805EnCor MRI Introducer Set, EnCor Probe IntroducerSenorx, Inc. K153337Corvocet Biopsy SystemMerit Medical Systems, 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.

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