← Product Code [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX) · K961228 # KARL STORZ MAGNIFYING ARTHROSOCPES (K961228) _KARL STORZ Endoscopy-America, Inc. · HRX · Oct 10, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K961228 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX.md) - **Decision Date:** Oct 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.1100 - **Device Class:** Class 2 - **Review Panel:** Orthopedic ## Intended Use The KSEA magnifying arthroscopes and accessories are intended for use by qualified surgeons during arthroscopic procedures of the small and large joints. Specific arthroscope models are intended for arthroscopic procedures of the shoulder and knee; arthroscopic procedures of the elbow, ankle, wrist and jaw; and arthroscopic procedures for the shoulder, knee and illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint”. ## Device Story Manually operated, reusable rigid arthroscope; features integrated ring for image magnification adjustment. Used by surgeons in clinical/OR settings for joint visualization. Provides optical access to surgical sites; aids diagnosis and loose body removal. Stainless steel construction. No electronic or automated processing. ## Clinical Evidence Bench testing only. ## Technological Characteristics Rigid arthroscope; surgical grade stainless steel; manual magnification adjustment ring; reusable. ## Regulatory Identification An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint. ## 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} STORZ Karl Storz Endoscopy 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 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS *K961778* 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 **OCT 10 1996** **Contact:** Marika Anderson Senior Regulatory Affairs Specialist **Device Identification:** Common Name Arthroscope Trade Name Karl Storz Magnifying Arthroscope **Indication:** The KSEA magnifying arthroscopes and accessories are intended for use by qualified surgeons during arthroscopic procedures of the small and large joints. Specific arthroscope models are intended for arthroscopic procedures of the shoulder and knee; arthroscopic procedures of the elbow, ankle, wrist and jaw; and arthroscopic procedures for the shoulder, knee and illumination and visualization of the hip joint to diagnose disease and for the removal of loose bodies in the hip joint”. **Device Description:** The KSEA magnifying arthroscopes are manually operated, reusable surgical devices consisting of a rigid arthroscope with a ring for adjusting the magnification of the image. The arthroscopes are long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel. **Substantial Equivalence:** The KSEA magnifying arthroscopes and accessories 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 KSEA magnifying arthroscopes 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/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K961228](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K961228) **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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