Model TR Rectal Suction Biopsy Tube
FDA 510(k) K902097 · Medical Measurements, Inc.
510(k) numberK902097
Submission
- Device name
- Model TR Rectal Suction Biopsy Tube
- Applicant
- Medical Measurements, Inc.
Hackensack, NJ, US - Received
- May 8, 1990
- Decision date
- July 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCK – Instrument, Biopsy, Suction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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| 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 |
| K062159 | RB12 Suction Rectal Biopsy SystemFCK · Traditional | Aus Systems Pty , Ltd. | 09/05/2006SE |
| 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 |
More from H & B Medical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921062 | Gaeltec MPR SeriesFFX · Traditional | 07/30/1992SE |
| K863479 | Modified Ict/B Intracranial Press. Trans. EpiduralGWM · Traditional | 10/14/1986SE |
| K801757 | Mmi/Gaeltec Catheter Tip Press. TransduFES · Traditional | 08/27/1980SE |
| K801756 | Mmi/Gaeltec Catheter Tip TransducDXO · Traditional | 08/20/1980SE |
| K801880 | Mmi/Gaeltec Series 8T Diff. Press. TransBYR · Traditional | 08/14/1980SE |
| K801758 | Mmi/Gaeltec Catheter IntrauterineKXO · Traditional | 08/14/1980SE |
| K801755 | Mmi/Gaeltec Catheter Tip PressureGWM · Traditional | 08/13/1980SE |
Questions and answers
When was Model TR Rectal Suction Biopsy Tube cleared by the FDA?
Model TR Rectal Suction Biopsy Tube (K902097) received a 510(k) decision of Substantially Equivalent on July 27, 1990, 80 days after the submission was received.
What is the product code of K902097?
The FDA product code is FCK – Instrument, Biopsy, Suction, a Class II (moderate risk) device regulated under 21 CFR 876.1075.