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FDA 510(k)

ROTEX SCREW BIOPSY NEEDLE

K-Number: K854404 · 1985-12-02

ApplicantMeadox Surgimed, Inc.
Decision Date1985-12-02
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ROTEX SCREW BIOPSY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Surgimed, Inc.. It received FDA 510(k) clearance on 1985-12-02 under 510(k) number K854404. 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 ROTEX SCREW BIOPSY NEEDLE?

ROTEX SCREW BIOPSY NEEDLE is a medical device that received FDA 510(k) clearance on 1985-12-02. The listed applicant is Meadox Surgimed, Inc.. The 510(k) number is K854404.

When did ROTEX SCREW BIOPSY NEEDLE receive FDA 510(k) clearance?

ROTEX SCREW BIOPSY NEEDLE received FDA 510(k) clearance on 1985-12-02, under 510(k) number K854404.

Who is the listed applicant for ROTEX SCREW BIOPSY NEEDLE?

The FDA 510(k) record lists Meadox Surgimed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTEX SCREW BIOPSY NEEDLE?

The FDA product code for ROTEX SCREW BIOPSY NEEDLE is FCG.

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Other records listing Meadox Surgimed, Inc. as applicant

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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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