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FDA 510(k)

SIMON BREAST LESION LOCALIZATION NEEDLE

K-Number: K914941 · 1992-05-14

ApplicantManan Medical Products, Inc.
Decision Date1992-05-14
Product CodeGDF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIMON BREAST LESION LOCALIZATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Manan Medical Products, Inc.. It received FDA 510(k) clearance on 1992-05-14 under 510(k) number K914941. 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 SIMON BREAST LESION LOCALIZATION NEEDLE?

SIMON BREAST LESION LOCALIZATION NEEDLE is a medical device that received FDA 510(k) clearance on 1992-05-14. The listed applicant is Manan Medical Products, Inc.. The 510(k) number is K914941.

When did SIMON BREAST LESION LOCALIZATION NEEDLE receive FDA 510(k) clearance?

SIMON BREAST LESION LOCALIZATION NEEDLE received FDA 510(k) clearance on 1992-05-14, under 510(k) number K914941.

Who is the listed applicant for SIMON BREAST LESION LOCALIZATION NEEDLE?

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

What is the FDA product code for SIMON BREAST LESION LOCALIZATION NEEDLE?

The FDA product code for SIMON BREAST LESION LOCALIZATION NEEDLE is GDF.

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Other records listing Manan Medical Products, 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.

K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLEK011209MANAN SPRITACRE SPINAL NEEDLESK983620MANAN SPINAL NEEDLESK980536EPIDURAL NEEDLEK981386MANAN BLUNT NEEDLEK980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

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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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