3F Electrode

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K864904 ↗

FDA Product Code

FFK

Device Class

Class II

Regulation

21 CFR Part 876.4480

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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  Class II

  FDA 510(k) K891252 Active Cleared 22 Mar 1989

• Urological Stone Basket

  Class II

  FDA 510(k) K891254 Active Cleared 22 Mar 1989

• 5F Electrode(Lithotriptor)

  Class II

  FDA 510(k) K852874 Active Cleared 21 Aug 1985

• Model Sd-1 Disintegrator

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  FDA 510(k) K802322 Active Cleared 10 Nov 1980

• Urological Grasping Forceps

  Class II

  FDA 510(k) K891253 Active Cleared 22 Mar 1989

• 1.9 French Lithotripter Electrode

  Class II

  FDA 510(k) K903337 Active Cleared 16 Nov 1990

See all devices from Northgate Research, Inc. →

• What clinical procedures is the 3F Electrode designed to assist with, and how is it typically inserted?

  The 3F Electrode is specifically designed for use in urological and gastroenterological procedures, particularly as an electrohydraulic lithotripter electrode during lithotripsy—the process of breaking down urinary stones. It is inserted via ureteroscopy or cystoscopy, meaning it is advanced through the urethra into the bladder or ureter to deliver focused electrical energy that fragments stones. This makes it ideal for minimally invasive stone removal in controlled settings like operating rooms or endoscopy suites.

• Is the 3F Electrode intended for single-use or reusable applications, and what does this mean for clinical workflow?

  The 3F Electrode is single-use only, meaning each sterile electrode is designed for one procedure and must not be reused. This ensures patient safety by eliminating cross-contamination risks and simplifies clinical workflows, as no reprocessing (e.g., cleaning or sterilization) is required between uses. Clinicians should open the sterile packaging immediately before use and discard it post-procedure.

• What size is the 3F Electrode, and how does this relate to its compatibility with standard urological instruments?

  The electrode has a nominal size of 3 French, which is a standard measurement for thin, flexible catheters or electrodes used in urological procedures. This size allows it to be safely inserted through the urethra and advanced via ureteroscopy or cystoscopy without causing undue trauma. Its slim profile also ensures compatibility with most standard urological instruments and working channels in endoscopes.

• How should the 3F Electrode be stored, and what precautions should be taken to maintain its sterility?

  The electrode is supplied in a sterile packaging, so it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or moisture. The packaging seal must remain intact until use to preserve sterility. Clinicians should check the expiration date on the packaging and avoid exposing the device to contaminants (e.g., dust, chemicals) that could compromise its sterile condition before insertion.

• What regulatory pathway was followed for FDA clearance of the 3F Electrode, and how does this affect its use in clinical practice?

  The 3F Electrode was cleared via the Traditional 510(k) pathway (K864904) and is classified as a Class II medical device under FDA regulations (21 CFR 876.4480). This means it underwent a premarket submission to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and performance standards. Clinicians can rely on its FDA clearance as evidence of regulatory scrutiny, though they should always follow manufacturer instructions and institutional protocols for proper use.