Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1080](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1080) → QFZ — Gastroenterology-Urology Accessories To A Biopsy Instrument

# QFZ · Gastroenterology-Urology Accessories To A Biopsy Instrument

_Gastroenterology, Urology · 21 CFR 876.1080 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/QFZ

## Overview

- **Product Code:** QFZ
- **Device Name:** Gastroenterology-Urology Accessories To A Biopsy Instrument
- **Regulation:** [21 CFR 876.1080](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1080)
- **Device Class:** 1
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/QFZ](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/QFZ)

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