RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537— 510(k) K071048

Name: FDA 510(k) clearance K071048
Creator: U.S. Food and Drug Administration
Published: 2007-05-15

Substantially Equivalent

Rubicor Medical, Inc.

FDA 510(k) clearance K071048 for RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537, Substantially Equivalent on 2007-05-15. Applicant: Rubicor Medical, Inc.. Device class: 2.

Clearance details

Applicant: Rubicor Medical, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 2007-04-13
Decision date: 2007-05-15
Decision: Substantially Equivalent
Clearance type: Special
Location: San Carlos, CA, US

Download summary PDF View on FDA.gov ↗

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K070275 — FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE2007-03-09
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K052506 — RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 311082005-10-06
K032584 — RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 306292003-09-17
K030049 — MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 300862003-01-29

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.