Instrument, Biopsy, Suction
The Suction Biopsy Instrument (product code FCK) is a device that uses suction to draw tissue into a cutting aperture for specimen collection from the gastrointestinal or genitourinary mucosa. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FCK
- Device Class
- FDA class 2
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K153763 | Howell Biliary Aspiration Needle | Apr 06, 2017 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
| K103326 | MULTIPLE BIOPSY SYSTEM | Apr 06, 2011 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K062159 | RB12 SUCTION RECTAL BIOPSY SYSTEM | Sep 05, 2006 | Substantially Equivalent | Aus Systems Pty , Ltd. |
| K061201 | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 | May 30, 2006 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K051637 | DSNARE, MODEL 00711087 | Oct 31, 2005 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K954693 | MEHTA BRONCHIAL BIOSPY DRILL | Oct 23, 1995 | Substantially Equivalent | United States Endoscopy Group, Inc. |
| K944252 | BIOPSY DEVICE ACCESSORY | Dec 05, 1994 | Substantially Equivalent | Biopsys Medical, Inc. |
| K932142 | SUCTION GUILLOTINE DEVICE | Sep 24, 1993 | Substantially Equivalent | Triton Technology, Inc. |
| K911448 | MULTIPLE BIOPSY DEVICE-MBX | Apr 16, 1991 | Substantially Equivalent | Triton Technology, Inc. |
| K902910 | CYTOASPIRATOR | Jan 16, 1991 | Substantially Equivalent | H & B Medical Technology, Inc. |
| K902097 | MODEL TR RECTAL SUCTION BIOPSY TUBE | Jul 27, 1990 | Substantially Equivalent | Medical Measurements, Inc. |
| K895420 | SUCTION BIOPSY INSTRUMENT | Feb 09, 1990 | Substantially Equivalent | Mill-Rose Laboratory |
| K895900 | WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE | Jan 11, 1990 | Substantially Equivalent | Wilson-Cook Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.