Trocar Style Needle/Co-Axial Introducer Needle

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K954265 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Automated Vitrectomy Device

  Class II

  FDA 510(k) K961078 Active Cleared 14 Jun 1996

• Chiba, Franseen, Westcott, Spinal Style Aspiration Biopsy Needle

  Class II

  FDA 510(k) K945146 Active Cleared 21 Dec 1994

• Breast Lesion Localization Needle

  Class I

  FDA 510(k) K945124 Active Cleared 22 Nov 1994

• Augastroenterology-Urology Biopsy Instrument

  Class II

  FDA 510(k) K954231 Active Cleared 22 Sep 1995

• Surgical Cutter

  Class II

  FDA 510(k) K955168 Active Cleared 22 Jan 1996

• Co-Axial Introducer Needle

  Class II

  FDA 510(k) K022634 Active Cleared 6 Nov 2002

See all devices from Promex, Inc. →

• What types of medical procedures is this trocar-style needle designed to assist with, and why is it beneficial in those settings?

  This trocar-style needle/co-axial introducer needle is specifically designed for gastroenterology and urology procedures, particularly to facilitate the insertion of biopsy instruments or catheters. Its trocar-style and co-axial design help minimize tissue trauma and provide improved access during minimally invasive interventions, reducing complications and patient discomfort compared to traditional methods.

• Is this device reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

  The device is intended for single-use only and is supplied sterile. To preserve sterility, it must be handled according to standard sterile instrument protocols—keeping the packaging intact until use, avoiding contamination, and adhering to manufacturer guidelines for storage and preparation.

• What sizes or models of this trocar-style needle are available, and how might a clinician choose the right one for a procedure?

  While the provided data does not specify exact sizes or model variations, the device is categorized under product code KNW, which typically includes different gauges or lengths for biopsy introducers. Selection would depend on the procedure requirements, tissue type, and instrument compatibility—clinicians should refer to the manufacturer’s documentation for recommended sizes based on their specific application.

• How is this device regulated, and what does its FDA clearance mean for its use in clinical settings?

  This device holds an FDA 510(k) clearance (K954265) under Class II special controls, meaning it has been deemed substantially equivalent to a legally marketed predicate device. This clearance confirms it meets regulatory standards for safety and effectiveness in its intended use—facilitating minimally invasive biopsy or catheter insertion in gastroenterology and urology—but does not imply approval for any specific clinical indication beyond its labeled purpose.