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FDA 510(k)

BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT

K-Number: K845038 · 1985-03-11

ApplicantRanfac, Corp.
Decision Date1985-03-11
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Ranfac, Corp.. It received FDA 510(k) clearance on 1985-03-11 under 510(k) number K845038. 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 BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT?

BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT is a medical device that received FDA 510(k) clearance on 1985-03-11. The listed applicant is Ranfac, Corp.. The 510(k) number is K845038.

When did BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT receive FDA 510(k) clearance?

BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT received FDA 510(k) clearance on 1985-03-11, under 510(k) number K845038.

Who is the listed applicant for BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT?

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

What is the FDA product code for BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT?

The FDA product code for BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT is GDF.

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Other records listing Ranfac, 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.

K162932Ranfac Fat Aspiration CannulaK131157RANFAC BONE MARROW ASPIRATION NEEDLEK031344RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLEK012224SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROWK961922RDP-2K951090INTRODUCER

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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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