FDA 510(k)

RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629

K-Number: K032584 · 2003-09-17

Decision Date2003-09-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 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 2003-09-17 under 510(k) number K032584. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629?

RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 is a medical device that received FDA 510(k) clearance on 2003-09-17. The listed applicant is Rubicor Medical, Inc.. The 510(k) number is K032584.

When did RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 receive FDA 510(k) clearance?

RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 received FDA 510(k) clearance on 2003-09-17, under 510(k) number K032584.

Who is the listed applicant for RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629?

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 ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629?

The FDA product code for RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629 is GEI.

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Other records listing Rubicor Medical, Inc. as applicant

K071048RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537 K070275FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE K053151RUBICOR MAGIC BREAST BIOPSY DEVICE K052506RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108 K030049MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 K023601RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

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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.