FDA Product Code
FDA Product Code FCK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1075
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153763 | Howell Biliary Aspiration Needle | Wilson-Cook Medical, Inc. | 2017-04-06 | Traditional | PDF ↗ |
| K103326 | MULTIPLE BIOPSY SYSTEM | United States Endoscopy Group, Inc. | 2011-04-06 | Traditional | PDF ↗ |
| K062159 | RB12 SUCTION RECTAL BIOPSY SYSTEM | Aus Systems Pty , Ltd. | 2006-09-05 | Traditional | PDF ↗ |
| K061201 | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 | United States Endoscopy Group, Inc. | 2006-05-30 | Special | PDF ↗ |
| K051637 | DSNARE, MODEL 00711087 | United States Endoscopy Group, Inc. | 2005-10-31 | Traditional | PDF ↗ |
| K954693 | MEHTA BRONCHIAL BIOSPY DRILL | United States Endoscopy Group, Inc. | 1995-10-23 | Traditional | PDF ↗ |
| K944252 | BIOPSY DEVICE ACCESSORY | Biopsys Medical, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K932142 | SUCTION GUILLOTINE DEVICE | Triton Technology, Inc. | 1993-09-24 | Traditional | PDF ↗ |
| K911448 | MULTIPLE BIOPSY DEVICE-MBX | Triton Technology, Inc. | 1991-04-16 | Traditional | PDF ↗ |
| K902910 | CYTOASPIRATOR | H & B Medical Technology, Inc. | 1991-01-16 | Traditional | PDF ↗ |
| K902097 | MODEL TR RECTAL SUCTION BIOPSY TUBE | Medical Measurements, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K895420 | SUCTION BIOPSY INSTRUMENT | Mill-Rose Laboratory | 1990-02-09 | Traditional | PDF ↗ |
| K895900 | WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE | Wilson-Cook Medical, Inc. | 1990-01-11 | Traditional | PDF ↗ |
Product code FCK · Class II · Gastroenterology, Urology. Data: openFDA.