Panels › Gastroenterology, Urology › Product code FCK · Class 2
Instrument, Biopsy, Suction
Regulation 876.1075
0510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in FCK
| Company | 510(k)s | Recalls |
|---|---|---|
| United States Endoscopy Group, Inc. | 4 | 0 |
| Triton Technology, Inc. | 2 | 0 |
| Wilson-Cook Medical, Inc. | 2 | 0 |
| Aus Systems Pty , Ltd. | 1 | 0 |
| Bard Peripheral Vascular Inc | 0 | 1 |
| Biopsys Medical, Inc. | 1 | 0 |
| H & B Medical Technology, Inc. | 1 | 0 |
| Medical Measurements, Inc. | 1 | 0 |
| Mill-Rose Laboratory | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 6, 2017 | K153763 | Howell Biliary Aspiration Needle Wilson-Cook Medical, Inc. | FCK |
| Apr 6, 2011 | K103326 | MULTIPLE BIOPSY SYSTEM United States Endoscopy Group, Inc. | FCK |
| Sep 5, 2006 | K062159 | RB12 SUCTION RECTAL BIOPSY SYSTEM Aus Systems Pty , Ltd. | FCK |
| May 30, 2006 | K061201 | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 United States Endoscopy Group, Inc. | FCK |
| Oct 31, 2005 | K051637 | DSNARE, MODEL 00711087 United States Endoscopy Group, Inc. | FCK |
| Oct 23, 1995 | K954693 | MEHTA BRONCHIAL BIOSPY DRILL United States Endoscopy Group, Inc. | FCK |
| Dec 5, 1994 | K944252 | BIOPSY DEVICE ACCESSORY Biopsys Medical, Inc. | FCK |
| Sep 24, 1993 | K932142 | SUCTION GUILLOTINE DEVICE Triton Technology, Inc. | FCK |
| Apr 16, 1991 | K911448 | MULTIPLE BIOPSY DEVICE-MBX Triton Technology, Inc. | FCK |
| Jan 16, 1991 | K902910 | CYTOASPIRATOR H & B Medical Technology, Inc. | FCK |
| Jul 27, 1990 | K902097 | MODEL TR RECTAL SUCTION BIOPSY TUBE Medical Measurements, Inc. | FCK |
| Feb 9, 1990 | K895420 | SUCTION BIOPSY INSTRUMENT Mill-Rose Laboratory | FCK |
| Jan 11, 1990 | K895900 | WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE Wilson-Cook Medical, Inc. | FCK |
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