QFZ · Gastroenterology-Urology Accessories To A Biopsy Instrument
Gastroenterology, Urology · 21 CFR 876.1080 · Class 1
Overview
| Product Code | QFZ |
|---|---|
| Device Name | Gastroenterology-Urology Accessories To A Biopsy Instrument |
| Regulation | 21 CFR 876.1080 |
| Device Class | Class 1 |
| Review Panel | Gastroenterology, Urology |
Identification
A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.
Classification Rationale
Class I (general controls). The device is 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 (0 of 0)
No cleared devices on record.
