← Product Code [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG) · K961185

# DAUM BIOPSYNEEDLE (K961185)

_Ferguson Medical · FCG · Apr 30, 1996 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K961185

## Device Facts

- **Applicant:** Ferguson Medical
- **Product Code:** [FCG](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG.md)
- **Decision Date:** Apr 30, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1075
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology

## Intended Use

The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, biopsy of breast, lung, kidney, liver, lymph nodes, and prostate.

## Device Story

Daum BiopsyNeedle; standard soft-tissue biopsy needle; used for percutaneous or open surgical biopsies. Input: manual operation by clinician to obtain tissue samples from organs (breast, lung, kidney, liver, lymph nodes, prostate). Output: tissue specimen for diagnostic analysis. Device design utilizes titanium and titanium alloys for construction. Used in clinical or surgical settings by physicians to facilitate tissue sampling for pathological evaluation; aids in diagnosis of disease states.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Soft-tissue biopsy needle; materials of construction include titanium and titanium alloys. Manual operation; no energy source or software components.

## Regulatory 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.

## Predicate Devices

- Baxter (Pharmaseal) TruCut ([K813338](/device/K813338.md))
- MD Tech Ultra-Core Biopsy Needle

## Submission Summary (Full Text)

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{0}

P06
K961185
APR 30 1996
916-342-4133
FAX: 916-343-4541

23 April 1996

# 510(k) SUMMARY

The 510(k) summary information required by 21 CFR 807.92 is as follows:

A. Classification name: Set, biopsy needle and needle, gastroenterology, or instrument, biopsy

Common/usual name: Biopsy needle

Proprietary name: Daum BiopsyNeedle

B. Substantial equivalence: Baxter (Pharmaseal) TruCut (K813338), MD Tech Ultra-Core Biopsy Needle, and others.

C. Device description: The Daum BiopsyNeedle is a standard soft-tissue biopsy needle.

D. Intended use: The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, biopsy of breast, lung, kidney, liver, lymph nodes, and prostate.

E. Technological characteristics: The Daum BiopsyNeedle is similar to predicate devices

3407 Bay Avenue • Chico, California 95973 • USA

{1}

916 343 4541
FERGUSON MEDICAL
K961185

Page 2 of 2
SMDA Summary
23 April 1996

in its design, function, and intended use.

The proposed device is different than many
biopsy needles in that the Daum device has
components manufactured of titanium and titanium alloys, rather than from stainless steel.

Submitted,
FERGUSON MEDICAL
Establishment Registration Number 2937794

Frank Ferguson
Official Correspondent

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K961185](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FCG/K961185)

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