← Product Code [MQW](/submissions/EN/subpart-e%E2%80%94surgical-devices/MQW) · K962032 # KARL STORZ TWIN TRANSILLUMINATOR (K962032) _KARL STORZ Endoscopy-America, Inc. · MQW · Jul 5, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/MQW/K962032 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [MQW](/submissions/EN/subpart-e%E2%80%94surgical-devices/MQW.md) - **Decision Date:** Jul 5, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4350 - **Device Class:** Class 1 - **Review Panel:** Ear, Nose, Throat ## Indications for Use The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures. ## Device Story Manual, reusable, nonsterile transilluminator; used in ENT procedures to transilluminate sinus tissue. Device provides localized light source to assist physician visualization of sinus anatomy. Operates via fiber optic or standard illumination; handheld by clinician. No electronic processing or automated output; purely mechanical/optical tool for visual guidance during surgery or examination. ## Clinical Evidence Bench testing only; no clinical data provided. Biocompatibility of body-contact materials established via historical use in medical devices. ## Technological Characteristics Manual, reusable, nonsterile transilluminator. Fiber optic or standard light transmission. Materials have established history of biocompatibility. No electronic components, software, or energy source beyond external light coupling. ## Regulatory Identification An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope. ## 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} K962032 600 Corporate Events 600 Corporate Events 1000 1000 1000 1000 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge. **Applicant:** Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500 **Contact:** Betty M. Johnson Manager, Regulatory Affairs **Device Identification:** Common Name Transilluminator Trade Name Karl Storz Universal Twin Transilluminator Karl Storz Universal Fiber Optic Twin Transilluminator **Indication:** The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are designed to transilluminate sinus tissue during ENT procedures. **Device Description:** The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are manual, reusable, nonsterile medical devices. The body contact materials of these devices have a long history of biocompatibility with medical devices. **Substantial Equivalence:** The Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the Karl Storz Universal Twin Transilluminator and Universal Fiber Optic Twin Transilluminator and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices. Signed: Marika Anderson Marika Anderson Regulatory Affairs Specialist 000038 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/MQW/K962032](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/MQW/K962032) **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. 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