← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K960768 # LASER FIBER DELIVERY/CLEANING CATHETER (K960768) _Cook Urological, Inc. · GEX · May 14, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K960768 ## Device Facts - **Applicant:** Cook Urological, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** May 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## 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. ## Regulatory 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) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K960768](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K960768) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com