510(k) K895420
- Device
- SUCTION BIOPSY INSTRUMENT
- Applicant
- MILL-ROSE LABORATORY
- 510(k) number
- K895420
- Product code
- FCK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-09
- Date received
- 1989-09-01
- Regulation
- 876.1075
- Classification name
- Instrument, Biopsy, Suction
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARK KOZAK
- Address
- 7310 Corporate Blvd. Mentor OH US 44060 44060
FDA Registration Numbers#
- 3004681601
- 9680770
- 3005921952
- 3002808271
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCK #
| 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 |
| K895900 | WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE | Wilson-Cook Medical, Inc. | 1990-01-11 |
Legacy Summary#
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FDA Review#
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