FCK · Instrument, Biopsy, Suction
Gastroenterology, Urology · 21 CFR 876.1075 · Class 2
Overview
| Product Code | FCK |
|---|---|
| Device Name | Instrument, Biopsy, Suction |
| Regulation | 21 CFR 876.1075 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Classification Rationale
(1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Recent Cleared Devices (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153763 | Howell Biliary Aspiration Needle | Wilson-Cook Medical, Inc. | Apr 6, 2017 | SESE |
| K103326 | MULTIPLE BIOPSY SYSTEM | United States Endoscopy Group, Inc. | Apr 6, 2011 | SESE |
| K062159 | RB12 SUCTION RECTAL BIOPSY SYSTEM | Aus Systems Pty , Ltd. | Sep 5, 2006 | SESE |
| K061201 | DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087 | United States Endoscopy Group, Inc. | May 30, 2006 | SESE |
| K051637 | DSNARE, MODEL 00711087 | United States Endoscopy Group, Inc. | Oct 31, 2005 | SESE |
| K954693 | MEHTA BRONCHIAL BIOSPY DRILL | United States Endoscopy Group, Inc. | Oct 23, 1995 | SESE |
| K944252 | BIOPSY DEVICE ACCESSORY | Biopsys Medical, Inc. | Dec 5, 1994 | SESE |
| K932142 | SUCTION GUILLOTINE DEVICE | Triton Technology, Inc. | Sep 24, 1993 | SESE |
| K911448 | MULTIPLE BIOPSY DEVICE-MBX | Triton Technology, Inc. | Apr 16, 1991 | SESE |
| K902910 | CYTOASPIRATOR | H & B Medical Technology, Inc. | Jan 16, 1991 | SESE |
| K902097 | MODEL TR RECTAL SUCTION BIOPSY TUBE | Medical Measurements, Inc. | Jul 27, 1990 | SESE |
| K895420 | SUCTION BIOPSY INSTRUMENT | Mill-Rose Laboratory | Feb 9, 1990 | SESE |
| K895900 | WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE | Wilson-Cook Medical, Inc. | Jan 11, 1990 | SESE |
Top Applicants
- United States Endoscopy Group, Inc. — 4 clearances
- Wilson-Cook Medical, Inc. — 2 clearances
- Triton Technology, Inc. — 2 clearances
- Mill-Rose Laboratory — 1 clearance
- Medical Measurements, Inc. — 1 clearance
