Rubicor Breast Biopsy Device
FDA 510(k) K020047 · Rubicor Medical, Inc.
510(k) numberK020047
Submission
- Device name
- Rubicor Breast Biopsy Device
- Applicant
- Rubicor Medical, Inc.
San Carlos, CA, US - Received
- January 7, 2002
- Decision date
- April 5, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K071048 | Rubicor Magic Breast Biopsy Device, Model 31537KNW · Special | 05/15/2007SE |
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| K053151 | Rubicor Magic Breast Biopsy DeviceKNW · Traditional | 11/18/2005SE |
| K052506 | Rubicor Encapsule Breast Biopsy Device, Model 31108GEI · Special | 10/06/2005SE |
| K032584 | Rubicor Encapsule Breast Biopsy Device, Model 30629GEI · Special | 09/17/2003SE |
| K030049 | Modification to Rubicor Encapsule Breast Biopsy Device, Model 30086GEI · Special | 01/29/2003SE |
| K023601 | Rubicor Encapsule Breast Biopsy Device, Model 30086GEI · Special | 11/19/2002SE |
Questions and answers
When was Rubicor Breast Biopsy Device cleared by the FDA?
Rubicor Breast Biopsy Device (K020047) received a 510(k) decision of Substantially Equivalent on April 5, 2002, 88 days after the submission was received.
What is the product code of K020047?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.