510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Rubicor Medical, Inc.

San Carlos, CA, US

Rubicor Medical, Inc. appears in FDA device records in San Carlos, CA. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Rubicor Medical, Inc. between 2002 and 2007. The busiest year on record is 2002, with 2. The most recent is 2007, with 2.

Clearances by year, as a table
510(k) clearance decisions for Rubicor Medical, Inc., by decision year
YearClearances
20022
20032
20052
20072
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K071048RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537KNWSubstantially Equivalent
K070275FLEXIBLE LOOP ELECTROSURGICAL ELECTRODEGEISubstantially Equivalent
K053151RUBICOR MAGIC BREAST BIOPSY DEVICEKNWSubstantially Equivalent
K052506RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108GEISubstantially Equivalent
K032584RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629GEISubstantially Equivalent
K030049MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086GEISubstantially Equivalent
K023601RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086GEISubstantially Equivalent
K020047RUBICOR BREAST BIOPSY DEVICEGEISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0715-06Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063Devices' sterility may be compromised due to lack of adequate sterilization.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain