← Product Code [EOB](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB) · K963426 # KARL STORZ CONTACT MICRO-LARYNGOSCOPES (K963426) _KARL STORZ Endoscopy-America, Inc. · EOB · Nov 7, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K963426 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [EOB](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB.md) - **Decision Date:** Nov 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4760 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat ## Intended Use The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification. ## Device Story Manually operated, reusable surgical device; provides panoramic and high-magnification tissue contact visualization of larynx. Used by ENT surgeons during diagnostic and surgical procedures. Device provides direct optical visualization to assist in clinical decision-making and surgical navigation within the airway. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Constructed of surgical grade stainless steel. Manually operated, reusable optical instrument. Provides variable magnification. No energy source or software components. ## Regulatory Identification A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier. ## 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} K K Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 0837 Fax 310 410 5527 K963426 NOV - 7 1996 # 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:** Marika Anderson Senior Regulatory Affairs Specialist **Device Identification:** Common Name Micro-Laryngoscope Trade Name Karl Storz Contact Micro-Laryngoscopes **Indication:** The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification. **Device Description:** The KSEA Contact Micro-Laryngoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The Micro-Laryngoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel. **Substantial Equivalence:** The KSEA Contact Micro-Laryngoscope is 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 KSEA Contact Micro-Laryngoscope 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 Senior Regulatory Affairs Specialist --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K963426](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOB/K963426) **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