FDA 510(k)

RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537

K-Number: K071048 · 2007-05-15

Decision Date2007-05-15

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 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 2007-05-15 under 510(k) number K071048. 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, MODEL 31537?

RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 is a medical device that received FDA 510(k) clearance on 2007-05-15. The listed applicant is Rubicor Medical, Inc.. The 510(k) number is K071048.

When did RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 receive FDA 510(k) clearance?

RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 received FDA 510(k) clearance on 2007-05-15, under 510(k) number K071048.

Who is the listed applicant for RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537?

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, MODEL 31537?

The FDA product code for RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 is KNW.

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Other records listing Rubicor Medical, Inc. as applicant

K070275FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE K053151RUBICOR MAGIC BREAST BIOPSY DEVICE 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

View on FDA Database →

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