21 CFR 876.1075 — Instrument, Biopsy, Mechanical, Gastrointestinal
Gastroenterology, Urology (GU) · Subpart B—Diagnostic Devices · § 876.1075
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| FCF | Instrument, Biopsy, Mechanical, Gastrointestinal | 2 | 6 | 3rd Party |
| FCG | Biopsy Needle | 2 | 133 | 3rd Party |
| FCI | Punch, Biopsy | 2 | 5 | 3rd Party |
| FCK | Instrument, Biopsy, Suction | 2 | 13 | 3rd Party |
| FCL | Forceps, Biopsy, Non-Electric | 1 | 39 | |
| FFF | Cover, Biopsy Forceps | 1 | 1 | |
| KNW | Instrument, Biopsy | 2 | 360 | 3rd Party |
| NLS | Instrument, Biopsy, Reprocessed | 2 | 0 | 3rd Party |
| NMX | Needle And Needle Set, Gastro-Urology, Reprocessed | 2 | 0 | 3rd Party |
| NON | Forceps, Biopsy, Non-Electric, Reprocessed | 1 | 3 | 3rd Party |
| POZ | Biopsy Needle Kit | 2 | 0 | |
| PRV | Gastro-Urology Biopsy Kit | 2 | 0 | |
| QHC | Instrument, Biopsy, Core, Soft Tissue, Female Reproductive Organs | 2 | 0 |
