BIOPSY DEVICE ACCESSORY
FDA 510(k) clearance K944252 · decided 1994-12-05
Clearance details
- K-number
- K944252
- Device name
- BIOPSY DEVICE ACCESSORY
- Applicant
- Biopsys Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-30
- Decision date
- 1994-12-05
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- FCK
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Juan Capistrano, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Biopsys Medical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Howell Biliary Aspiration Needle (K153763) | Wilson-Cook Medical, Inc. | 2017-04-06 |
| MULTIPLE BIOPSY SYSTEM (K103326) | United States Endoscopy Group, Inc. | 2011-04-06 |
| RB12 SUCTION RECTAL BIOPSY SYSTEM (K062159) | Aus Systems Pty , Ltd. | 2006-09-05 |
| DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 (K061201) | United States Endoscopy Group, Inc. | 2006-05-30 |
| DSNARE, MODEL 00711087 (K051637) | United States Endoscopy Group, Inc. | 2005-10-31 |
| MEHTA BRONCHIAL BIOSPY DRILL (K954693) | United States Endoscopy Group, Inc. | 1995-10-23 |
| SUCTION GUILLOTINE DEVICE (K932142) | Triton Technology, Inc. | 1993-09-24 |
| MULTIPLE BIOPSY DEVICE-MBX (K911448) | Triton Technology, Inc. | 1991-04-16 |
| CYTOASPIRATOR (K902910) | H & B Medical Technology, Inc. | 1991-01-16 |
| MODEL TR RECTAL SUCTION BIOPSY TUBE (K902097) | Medical Measurements, Inc. | 1990-07-27 |
| SUCTION BIOPSY INSTRUMENT (K895420) | Mill-Rose Laboratory | 1990-02-09 |
| WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE (K895900) | Wilson-Cook Medical, Inc. | 1990-01-11 |
Recalls involving this device
No recalls on record reference this clearance.