(35 days)
The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, b10psy of breast, lung, kidney, liver, lymph nodes, and prostate.
The Daum BiopeyNeedle is a standard soft-tissue biopsy needle.
This 510(k) summary for the Daum BiopsyNeedle (K961185) does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm-based device evaluations. The document is concerned with demonstrating substantial equivalence to already marketed biopsy needles based on design, function, intended use, and material composition (titanium vs. stainless steel).
Therefore, I cannot provide the requested information from the given text. The provided text is a regulatory submission for a medical device that does not involve AI or complex performance metrics beyond basic functional equivalence for a biopsy needle.
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K961185
APR 3 0 1996
Image /page/0/Picture/5 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white.
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, instrument, or blopsy
Common/usual name: Biopsy needle
Proprietary name: Daum BiopsyNeedle
- B. Substantial eguivalence: Baxter ( Pharmaseal ) TruCut (K813338), MD Tech Ultra-Core B1opsy Needle, and others.
- C. Device description: The Daum BiopeyNeedle is a standard soft-tissue biopsy needle.
- Intended use: ענ The Daum BiopsyNeedle is intended for use in percutaneous or open surgical biopsies, including but not limited to, b10psy of breast, lung, kidney, liver, lymph nodes, and prostate.
- E. Technological characteristics: The Daum BiopsyNeedle 1s 81milar to predicate devices
3407 Bay Avenue · Chico, California 95973 · USA
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SMDA Summary 23 April 1996
in its design, function, and intended use.
is different than many The proposed device hiopsy 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 Lee
Prank Ferguson Official Correspondent
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (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.