Who is the manufacturer of DAUM BIOPSYNEEDLE?

Ferguson Medical filed the 510(k) submission for DAUM BIOPSYNEEDLE (K961185).

What is the FDA product code for DAUM BIOPSYNEEDLE?

FCG. It is classified under 21 CFR 876.1075 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for DAUM BIOPSYNEEDLE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DAUM BIOPSYNEEDLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DAUM BIOPSYNEEDLE

Q: What are the predicate devices for DAUM BIOPSYNEEDLE?

Baxter (Pharmaseal) TruCut (K813338); MD Tech Ultra-Core Biopsy Needle.

K961185 · Ferguson Medical · FCG · Apr 30, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K961185
Device Name	DAUM BIOPSYNEEDLE
Applicant	Ferguson Medical
Product Code	FCG · Gastroenterology, Urology
Decision Date	Apr 30, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

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.

Indications for Use

Indicated for patients requiring percutaneous or open surgical biopsy of soft tissues, including breast, lung, kidney, liver, lymph nodes, and prostate.

Regulatory Classification

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)
MD Tech Ultra-Core Biopsy Needle

Related Devices

K981796 — LIGHT SABER CORE TISSUE NEEDLE · Minrad, Inc. · Aug 5, 1998
K974575 — DAUM ASPIRATIONBIOPSY NEEDLE · Daum Corp. · Mar 6, 1998
K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit · Bard Peripheral Vascular, Inc. · Jul 10, 2025
K974446 — MANAN AUTOMATIC CUTTING NEEDLE · Manan Medical Products, Inc. · Jan 8, 1998
K964777 — TZ · Gallini Intl., Inc. · Jan 3, 1997

Submission Summary (Full Text)

{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