Suction Biopsy Instrument
FDA 510(k) K895420 · Mill-Rose Laboratory
510(k) numberK895420
Submission
- Device name
- Suction Biopsy Instrument
- Applicant
- Mill-Rose Laboratory
Mentor, OH, US - Received
- September 1, 1989
- Decision date
- February 9, 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 |
|---|---|---|
| K983124 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural KitEOQ · Traditional | 10/30/1998SE |
| K983122 | Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination…EOQ · Traditional | 10/30/1998SE |
| K971275 | Mill-Rose Disposable Polypectomy SnareFDI · Traditional | 05/23/1997SE |
| K962736 | Mill-Rose Laryngoscopic Injection NeedleEOQ · Traditional | 07/29/1996SE |
| K960880 | Mill-Rose Blind Microbiology BrushEOQ · Traditional | 04/29/1996SE |
| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | 12/22/1995SE |
| K951600 | Mill-Rose Rotatable Polypectomy SnareFDI · Traditional | 12/18/1995SE |
| K954745 | Mill-Rose Rigid Scope Cleaning BrushesFEB · Traditional | 11/27/1995SE |
| K951051 | Rite-Bite Biopsy ForcepsEOQ · Traditional | 03/24/1995SE |
| K951048 | Rite-Bite Biopsy ForcepsFCL · Traditional | 03/15/1995SE |
Questions and answers
When was Suction Biopsy Instrument cleared by the FDA?
Suction Biopsy Instrument (K895420) received a 510(k) decision of Substantially Equivalent on February 9, 1990, 161 days after the submission was received.
What is the product code of K895420?
The FDA product code is FCK – Instrument, Biopsy, Suction, a Class II (moderate risk) device regulated under 21 CFR 876.1075.