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FDA 510(k)

LOCALIZATION WIRE OR MARKER - SURGICAL

K-Number: K935457 · 1994-02-17

ApplicantBip USA, Inc.
Decision Date1994-02-17
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LOCALIZATION WIRE OR MARKER - SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Bip USA, Inc.. It received FDA 510(k) clearance on 1994-02-17 under 510(k) number K935457. The device is classified under product code GDF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOCALIZATION WIRE OR MARKER - SURGICAL?

LOCALIZATION WIRE OR MARKER - SURGICAL is a medical device that received FDA 510(k) clearance on 1994-02-17. The listed applicant is Bip USA, Inc.. The 510(k) number is K935457.

When did LOCALIZATION WIRE OR MARKER - SURGICAL receive FDA 510(k) clearance?

LOCALIZATION WIRE OR MARKER - SURGICAL received FDA 510(k) clearance on 1994-02-17, under 510(k) number K935457.

Who is the listed applicant for LOCALIZATION WIRE OR MARKER - SURGICAL?

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

What is the FDA product code for LOCALIZATION WIRE OR MARKER - SURGICAL?

The FDA product code for LOCALIZATION WIRE OR MARKER - SURGICAL is GDF.

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Other records listing Bip USA, Inc. 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.

K024089VACUFLASH BIOPSY SYSTEMK934371BIP MULTI MODIFICATIONK934370BIP BIOPSY NEEDLE MODIFICATIONK925870SPACERK925875HORIZONTAL NEEDLE GUIDE ATTACHMENTK925874BREAST STABILIZER

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Related Devices (Code: GDF)

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.

K031173NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc.K950311GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIREGlobal Medical Products, Ltd.K950007SURGICAL INSTRUMENT GUIDEUnited States Surgical, A Division of Tyco HealthcK945124BREAST LESION LOCALIZATION NEEDLEPromex, Inc.K944942BREAST LESION LOCALIZATION NEEDLEPromedical , Ltd.K935538BAUER TEMNO COAXIAL NEEDLEBauer Medical, 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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