Who is the manufacturer of LASER FIBER DELIVERY/CLEANING CATHETER?

Cook Urological, Inc. filed the 510(k) submission for LASER FIBER DELIVERY/CLEANING CATHETER (K960768).

What is the FDA product code for LASER FIBER DELIVERY/CLEANING CATHETER?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for LASER FIBER DELIVERY/CLEANING CATHETER?

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

What are the predicate devices for LASER FIBER DELIVERY/CLEANING CATHETER?

Lasercath™ (HGM Medical Laser Systems, Inc.); Continuous Flow Laser Cystoscope (CIRCON ACMI); Laser Fiber Insert (Cabot Medical).

Who can help prepare an FDA 510(k) submission like LASER FIBER DELIVERY/CLEANING CATHETER?

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.

LASER FIBER DELIVERY/CLEANING CATHETER

K960768 · Cook Urological, Inc. · GEX · May 14, 1996 · General, Plastic Surgery

Device Facts

Record ID	K960768
Device Name	LASER FIBER DELIVERY/CLEANING CATHETER
Applicant	Cook Urological, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	May 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2

Intended Use

The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber, for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site.

Device Story

Catheter device protects laser ablation fibers during surgery; enables intraoperative cleaning of charred/thermally degraded tissue from fiber tips; provides irrigation to surgical site. Available in 5.7Fr (accepts fibers up to 1250 microns) and 8.0Fr (accepts fibers up to 1500 microns) sizes. Used by clinicians in surgical settings. Device facilitates laser ablation by maintaining fiber integrity and site visibility; benefits patient by ensuring consistent laser performance and reducing need for fiber removal/replacement during procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on polyethylene materials confirms compliance with requirements. No clinical data provided.

Technological Characteristics

Materials: polyethylene (biocompatible), nylon, acetal, polyvinylchloride, polycarbonate. Dimensions: 5.7Fr (accepts up to 1250 micron fibers) and 8.0Fr (accepts up to 1500 micron fibers). Function: mechanical fiber protection, cleaning, and irrigation. Sterilization: consistent with existing company standards.

Indications for Use

Indicated for use during laser ablation procedures to protect laser fibers, clean charred tissue from fibers, and irrigate surgical sites. No specific patient population, age, or gender restrictions stated.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

Lasercath™ (HGM Medical Laser Systems, Inc.)
Continuous Flow Laser Cystoscope (CIRCON ACMI)
Laser Fiber Insert (Cabot Medical)

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K020673 — WAVE FORM MANUFACTURING PROLASE GENERAL SHAPED FIBER · Wave Form Mfg., Inc. · May 30, 2002
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Submission Summary (Full Text)

{0} 510(k) Premarket Notification Laser Fiber Delivery/Cleaning Catheter Cook Urological, Incorporated K960768 # L 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS MAY 14 1996 ## Submitted By: Rick Lykins Cook Urological, Incorporated 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 February 23, 1996 ## Device: Trade Name: Laser Fiber Delivery/Cleaning Catheter Proposed Classification Name: Endoscope and/or Accessories 78 KOG ## Predicate Devices: The Laser Fiber Delivery/Cleaning Catheter is substantially equivalent to predicate laser fiber delivery and laser fiber delivery/cleaning catheters in terms of indications for use, design, construction and materials equivalence. Predicate devices include: - Lasercath™ manufactured by HGM Medical Laser Systems, Inc. - Continuous Flow Laser Cystoscope manufactured by CIRCON ACMI. - Laser Fiber Insert manufactured by Cabot Medical. ## Device Description: The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber, for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site. The 5.7Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1250 microns (0.050 inch). The 8.0Fr Laser Fiber Delivery/Cleaning Catheter will accept laser fibers up to 1500 microns (0.060 inch). The materials used in this device are polyethylene, nylon, acetal, polyvinylchloride and polycarbonate. Biocompatibility testing has been performed on the polyethylene and results show the materials to meet the requirements of these tests. The nylon, acetal, polyvinylchloride and polycarbonate do not come into contact with body tissue. ## Substantial Equivalence: This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed by Cook Urological, Incorporated. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.