FDA 510(k)

RUBICOR MAGIC BREAST BIOPSY DEVICE

K-Number: K053151 · 2005-11-18

Decision Date2005-11-18

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RUBICOR MAGIC BREAST BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Rubicor Medical, Inc.. It received FDA 510(k) clearance on 2005-11-18 under 510(k) number K053151. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBICOR MAGIC BREAST BIOPSY DEVICE?

RUBICOR MAGIC BREAST BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 2005-11-18. The listed applicant is Rubicor Medical, Inc.. The 510(k) number is K053151.

When did RUBICOR MAGIC BREAST BIOPSY DEVICE receive FDA 510(k) clearance?

RUBICOR MAGIC BREAST BIOPSY DEVICE received FDA 510(k) clearance on 2005-11-18, under 510(k) number K053151.

Who is the listed applicant for RUBICOR MAGIC BREAST BIOPSY DEVICE?

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

What is the FDA product code for RUBICOR MAGIC BREAST BIOPSY DEVICE?

The FDA product code for RUBICOR MAGIC BREAST BIOPSY DEVICE is KNW.

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Other records listing Rubicor Medical, Inc. as applicant

K071048RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 K070275FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE K052506RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 K032584RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 K030049MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 K023601RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

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Related Devices (Code: KNW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.