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FDA 510(k)

RUBICOR BREAST BIOPSY DEVICE

K-Number: K020047 · 2002-04-05

ApplicantRubicor Medical, Inc.
Decision Date2002-04-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RUBICOR 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 2002-04-05 under 510(k) number K020047. 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 BREAST BIOPSY DEVICE?

RUBICOR BREAST BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 2002-04-05. The listed applicant is Rubicor Medical, Inc.. The 510(k) number is K020047.

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

RUBICOR BREAST BIOPSY DEVICE received FDA 510(k) clearance on 2002-04-05, under 510(k) number K020047.

Who is the listed applicant for RUBICOR 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 BREAST BIOPSY DEVICE?

The FDA product code for RUBICOR BREAST BIOPSY DEVICE is GEI.

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Other records listing Rubicor Medical, 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.

K071048RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537K070275FLEXIBLE LOOP ELECTROSURGICAL ELECTRODEK053151RUBICOR MAGIC BREAST BIOPSY DEVICEK052506RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108K032584RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629K030049MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086

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Related Devices (Code: GEI)

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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.

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