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FDA 510(k)

MODIFICATION TO TEMNO BIOPSY NEEDLES

K-Number: K024120 · 2003-01-15

ApplicantAllegiance Healthcare Corp.
Decision Date2003-01-15
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO TEMNO BIOPSY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Allegiance Healthcare Corp.. It received FDA 510(k) clearance on 2003-01-15 under 510(k) number K024120. 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 MODIFICATION TO TEMNO BIOPSY NEEDLES?

MODIFICATION TO TEMNO BIOPSY NEEDLES is a medical device that received FDA 510(k) clearance on 2003-01-15. The listed applicant is Allegiance Healthcare Corp.. The 510(k) number is K024120.

When did MODIFICATION TO TEMNO BIOPSY NEEDLES receive FDA 510(k) clearance?

MODIFICATION TO TEMNO BIOPSY NEEDLES received FDA 510(k) clearance on 2003-01-15, under 510(k) number K024120.

Who is the listed applicant for MODIFICATION TO TEMNO BIOPSY NEEDLES?

The FDA 510(k) record lists Allegiance Healthcare Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO TEMNO BIOPSY NEEDLES?

The FDA product code for MODIFICATION TO TEMNO BIOPSY NEEDLES is FCG.

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Other records listing Allegiance Healthcare Corp. as applicant

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.

K023673AIRLIFE DEMAND NASAL CANNULAK023419TRILAMINATE DRAPES/TIBURONK024292MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIMK024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMK023425DRAPES WITH ABSORBENT REINFORCEMENTK022765NITRILE POWDER-FREE EXAMINATION GLOVES

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Related Devices (Code: FCG)

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.

K252646Single-Use Fine Needle Biopsy (FNB) device (NA-U210H)Olympus Medical Systems Corp.K250994ClearTip FNA and FNB TypesFinemedix Co., Ltd.K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)Cook Ireland, Ltd.K231422Precision GILimaca Medical, Ltd.K231267ClearTipFinemedix Co., Ltd.K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)Cook Ireland, 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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