Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart B — Diagnostic Devices](/submissions/GU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 876.1075](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1075) → FCI — Punch, Biopsy

# FCI · Punch, Biopsy

_Gastroenterology, Urology · 21 CFR 876.1075 · Class 2_

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

## Overview

- **Product Code:** FCI
- **Device Name:** Punch, Biopsy
- **Regulation:** [21 CFR 876.1075](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/876.1075)
- **Device Class:** 2
- **Review Panel:** [Gastroenterology, Urology](/submissions/GU)
- **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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K895885](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCI/K895885.md) | AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTING | National-Standard Co. | Feb 9, 1990 | SESE |
| [K894627](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCI/K894627.md) | BT-338N ELECTRONIC CLINICAL THERMOMETER | Integrated Display Technology, Ltd. | Oct 23, 1989 | SESE |
| [K875119](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCI/K875119.md) | BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE | Advanced Diagnostic Medical Systems, Inc. | Mar 2, 1988 | SESE |
| [K853104](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCI/K853104.md) | DISPOSABLE, STERILE BIOPSY PUNCH | August C. Stiefel Research Institute, Inc. | Oct 4, 1985 | SESE |
| [K831317](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCI/K831317.md) | BIOPSY ATTACHMENT | Diasonics, Inc. | May 18, 1983 | SESE |

## Top Applicants

- Advanced Diagnostic Medical Systems, Inc. — 1 clearance
- August C. Stiefel Research Institute, Inc. — 1 clearance
- Diasonics, Inc. — 1 clearance
- Integrated Display Technology, Ltd. — 1 clearance
- National-Standard Co. — 1 clearance

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

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