RB12 Suction Rectal Biopsy System
FDA 510(k) K062159 · Aus Systems Pty , Ltd.
510(k) numberK062159
Submission
- Device name
- RB12 Suction Rectal Biopsy System
- Applicant
- Aus Systems Pty , Ltd.
Clearwater, FL, US - Received
- July 28, 2006
- Decision date
- September 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FCK – Instrument, Biopsy, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153763 | Howell Biliary Aspiration NeedleFCK · Traditional | Wilson-Cook Medical, Inc. | 04/06/2017SE |
| K103326 | Multiple Biopsy SystemFCK · Traditional | United States Endoscopy Group, Inc. | 04/06/2011SE |
| K061201 | Dsnare Diminutive Polypectomy and Suction System, Model 00711087FCK · Special | United States Endoscopy Group, Inc. | 05/30/2006SE |
| K051637 | Dsnare, Model 00711087FCK · Traditional | United States Endoscopy Group, Inc. | 10/31/2005SE |
| K954693 | Mehta Bronchial Biospy DrillFCK · Traditional | United States Endoscopy Group, Inc. | 10/23/1995SE |
| K944252 | Biopsy Device AccessoryFCK · Traditional | Biopsys Medical, Inc. | 12/05/1994SE |
| K932142 | Suction Guillotine DeviceFCK · Traditional | Triton Technology, Inc. | 09/24/1993SE |
| K911448 | Multiple Biopsy Device-MbxFCK · Traditional | Triton Technology, Inc. | 04/16/1991SE |
| K902910 | CytoaspiratorFCK · Traditional | H & B Medical Technology, Inc. | 01/16/1991SE |
| K902097 | Model TR Rectal Suction Biopsy TubeFCK · Traditional | Medical Measurements, Inc. | 07/27/1990SE |
Questions and answers
When was RB12 Suction Rectal Biopsy System cleared by the FDA?
RB12 Suction Rectal Biopsy System (K062159) received a 510(k) decision of Substantially Equivalent on September 5, 2006, 39 days after the submission was received.
What is the product code of K062159?
The FDA product code is FCK – Instrument, Biopsy, Suction, a Class II (moderate risk) device regulated under 21 CFR 876.1075.