Who is the manufacturer of 18 GAUGE TRU-CUT BIOPSY NEEDLE?

Baxter Healthcare Corp filed the 510(k) submission for 18 GAUGE TRU-CUT BIOPSY NEEDLE (K960509).

What is the FDA product code for 18 GAUGE TRU-CUT BIOPSY NEEDLE?

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

What is the regulatory pathway for 18 GAUGE TRU-CUT BIOPSY NEEDLE?

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

Who can help prepare an FDA 510(k) submission like 18 GAUGE TRU-CUT BIOPSY NEEDLE?

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.

18 GAUGE TRU-CUT BIOPSY NEEDLE

Q: What are the predicate devices for 18 GAUGE TRU-CUT BIOPSY NEEDLE?

Baxter 14 Gauge Tru-Cut Biopsy Needle.

K960509 · Baxter Healthcare Corp · KNW · Apr 4, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K960509
Device Name	18 GAUGE TRU-CUT BIOPSY NEEDLE
Applicant	Baxter Healthcare Corp
Product Code	KNW · Gastroenterology, Urology
Decision Date	Apr 4, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1075
Device Class	Class 2

Intended Use

The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation.

Device Story

18 gauge Tru-Cut Biopsy Needle; consists of cannula and stylet assembly with handle; used for soft tissue biopsy (breast, lung, lymph node, prostate); manual operation by clinician; device facilitates tissue sample collection for diagnostic evaluation.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 including USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization tests.

Technological Characteristics

18 gauge needle; cannula and stylet assembly; manual operation; materials evaluated per ISO 10993-1 biocompatibility standards.

Indications for Use

Indicated for patients requiring soft tissue diagnostic evaluation, including breast, lung, lymph node, and prostate tissue sampling.

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 14 Gauge Tru-Cut Biopsy Needle

Related Devices

K250032 — Marquee Disposable Core Biopsy Instrument and Instrument Kit · Bard Peripheral Vascular, Inc. · Jul 10, 2025
K203141 — Uramix CuraWay Biopsy Needle · Uramix, Inc. · Sep 17, 2021
K212819 — Disposable Biopsy Refill Needle · Suzhou Leapmed Healthcare Corporation · Jul 6, 2022
K974446 — MANAN AUTOMATIC CUTTING NEEDLE · Manan Medical Products, Inc. · Jan 8, 1998
K973565 — QUICK-CARE BIOPSY NEEDLE · Cook, Inc. · Nov 3, 1997

Submission Summary (Full Text)

{0} k960509 APR - 4 1996 Surgical Group Baxter Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847.473.1500 FAX: 847.785.2460 A # Baxter APR - 4 1996 # XII. SMDA REQUIREMENTS # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 18 GAUGE TRU-CUT BIOPSY NEEDLE Manufacturer: Baxter Healthcare Corporation Surgical Group 400 East Foster Road Mannford, OK 74044 Regulatory Affairs Contact: Sharon Richter Surgical Group 1500 Waukegan Road MPK McGaw Park, IL 60085 Telephone: (847) 785-3311 Date Summary Prepared: January, 1996 Common Name: 18 Gauge Tru-Cut Biopsy Needle Classification: Class II per 21CFR § 876.1075 Predicate Device: Baxter 14 Gauge Tru-Cut Biopsy Needle Description: The 18 gauge Tru-Cut Biopsy needle is comprised of a cannula and stylet assembly connected to a handle for ease of insertion into the soft tissue. {1} 13 # XII. SMDA REQUIREMENTS (continued) ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## 18 GAUGE TRU-CUT BIOPSY NEEDLE **Intended Use:** The 18 gauge Tru-Cut Biopsy Needle is a device that introduces a cannula into the soft tissue such as breast, lungs, lymph nodes and prostate, etc. for diagnostic evaluation. **Substantial Equivalence:** The Baxter 18 gauge Tru-Cut Biopsy Needle is substantially equivalent to Baxter’s 14 gauge Tru-Cut Biopsy Needle in that: - the intended use is the same - the performance attributes are the same **Summary of testing:** All materials used in the fabrication of this 18 gauge Tru-Cut Biopsy Needle were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 “Biological Evaluation of Medical Devices”. The biocompatibility tests performed were USP Plastics Class VI, Implant, Hemolysis, Tissue Culture, Pyrogenicity, Ocular Irritation, and Guinea Pig Maximization as required. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.