FCK — Instrument, Biopsy, Suction Class II
FDA product code FCK covers "Instrument, Biopsy, Suction", a Class II medical device regulated under 21 CFR 876.1075. Submissions are reviewed by the Gastroenterology, Urology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCK
- Device Class
- Class II
- Regulation Number
- 876.1075
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K153763 | Wilson-Cook Medical | Howell Biliary Aspiration Needle | Apr 6, 2017 |
| K103326 | United States Endoscopy Group | MULTIPLE BIOPSY SYSTEM | Apr 6, 2011 |
| K062159 | Aus Systems Pty | RB12 SUCTION RECTAL BIOPSY SYSTEM | Sep 5, 2006 |
| K061201 | United States Endoscopy Group | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 | May 30, 2006 |
| K051637 | United States Endoscopy Group | DSNARE, MODEL 00711087 | Oct 31, 2005 |
| K954693 | United States Endoscopy Group | MEHTA BRONCHIAL BIOSPY DRILL | Oct 23, 1995 |
| K944252 | Biopsys Medical | BIOPSY DEVICE ACCESSORY | Dec 5, 1994 |
| K932142 | Triton Technology | SUCTION GUILLOTINE DEVICE | Sep 24, 1993 |
| K911448 | Triton Technology | MULTIPLE BIOPSY DEVICE-MBX | Apr 16, 1991 |
| K902910 | H And B Medical Technology | CYTOASPIRATOR | Jan 16, 1991 |
| K902097 | Medical Measurements | MODEL TR RECTAL SUCTION BIOPSY TUBE | Jul 27, 1990 |
| K895420 | Mill-Rose Laboratory | SUCTION BIOPSY INSTRUMENT | Feb 9, 1990 |
| K895900 | Wilson-Cook Medical | WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE | Jan 11, 1990 |