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FDA 510(k)

MILLEREISEN CURVED BIOPSY NEEDLE

K-Number: K840157 · 1984-03-12

ApplicantPreventive Medicine Institute
Decision Date1984-03-12
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MILLEREISEN CURVED BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Preventive Medicine Institute. It received FDA 510(k) clearance on 1984-03-12 under 510(k) number K840157. 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 MILLEREISEN CURVED BIOPSY NEEDLE?

MILLEREISEN CURVED BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1984-03-12. The listed applicant is Preventive Medicine Institute. The 510(k) number is K840157.

When did MILLEREISEN CURVED BIOPSY NEEDLE receive FDA 510(k) clearance?

MILLEREISEN CURVED BIOPSY NEEDLE received FDA 510(k) clearance on 1984-03-12, under 510(k) number K840157.

Who is the listed applicant for MILLEREISEN CURVED BIOPSY NEEDLE?

The FDA 510(k) record lists Preventive Medicine Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MILLEREISEN CURVED BIOPSY NEEDLE?

The FDA product code for MILLEREISEN CURVED BIOPSY NEEDLE is FCG.

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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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