Product code FCK
- Device name
- Instrument, Biopsy, Suction
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1075
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153763 | Howell Biliary Aspiration Needle | Wilson-Cook Medical, Inc. | 2017-04-06 |
| K103326 | MULTIPLE BIOPSY SYSTEM | United States Endoscopy Group, Inc. | 2011-04-06 |
| K062159 | RB12 SUCTION RECTAL BIOPSY SYSTEM | Aus Systems Pty , Ltd. | 2006-09-05 |
| K061201 | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 | United States Endoscopy Group, Inc. | 2006-05-30 |
| K051637 | DSNARE, MODEL 00711087 | United States Endoscopy Group, Inc. | 2005-10-31 |
| K954693 | MEHTA BRONCHIAL BIOSPY DRILL | United States Endoscopy Group, Inc. | 1995-10-23 |
| K944252 | BIOPSY DEVICE ACCESSORY | Biopsys Medical, Inc. | 1994-12-05 |
| K932142 | SUCTION GUILLOTINE DEVICE | Triton Technology, Inc. | 1993-09-24 |
| K911448 | MULTIPLE BIOPSY DEVICE-MBX | Triton Technology, Inc. | 1991-04-16 |
| K902910 | CYTOASPIRATOR | H & B Medical Technology, Inc. | 1991-01-16 |
| K902097 | MODEL TR RECTAL SUCTION BIOPSY TUBE | Medical Measurements, Inc. | 1990-07-27 |
| K895420 | SUCTION BIOPSY INSTRUMENT | Mill-Rose Laboratory | 1990-02-09 |
| K895900 | WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE | Wilson-Cook Medical, Inc. | 1990-01-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00853277008084 | LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) | UVISION 360, INC. | 2021-08-13 |
| 00853277008091 | LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) | UVISION 360, INC. | 2021-08-13 |
| B194HP10001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | 2016-10-24 |
| B194SS10001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | 2016-10-24 |
| 09340254000632 | TREWAVIS SURGICAL | TREWAVIS SURGICAL INSTRUMENTS PTY LTD | 2016-10-20 |
| 00827002217911 | Howell | COOK INCORPORATED | 2016-09-24 |
| B194CP12001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | 2016-08-29 |
| B194MR1001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | 2016-08-29 |
| CP12000 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | 2016-08-29 |
| CP12001 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | 2016-08-29 |
| CP12002 | rbi2 suction rectal biopsy system | AUS SYSTEMS PTY. LIMITED. | 2016-08-29 |