← Product Code [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX) · K970055 # KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY (K970055) _KARL STORZ Endoscopy-America, Inc. · HRX · Mar 5, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K970055 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX.md) - **Decision Date:** Mar 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.1100 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ. ## Device Story Motorized surgical system for arthroscopy; includes Multidrive Mini Shaver and associated blades. Used in ankle, wrist, elbow, and TMJ procedures. Device provides controlled mechanical shaving, abrading, and cutting of bone and tissue. Operated by surgeons in clinical/OR settings. Blades are either reusable or sterile single-use instruments; designed as accessories to arthroscopes to access surgical sites. Output is mechanical tissue/bone removal; assists surgeon in site preparation or debridement. Benefits include precise tissue management during minimally invasive procedures. ## Clinical Evidence Bench testing only. ## Technological Characteristics Motorized surgical shaver system. Blades constructed from surgical grade stainless steel. Form factor includes long instruments for arthroscopic access. System includes both reusable and sterile single-use components. ## 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 K970055 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS MAR - 5 1997 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:** Renate A. MacLaren, Ph.D. Senior Regulatory Affairs Specialist **Device Identification:** **Common Name** Shaver for Arthroscopy Arthroscopic Shaver Blades **Trade Name** Karl Storz Multidrive Mini Shaver Karl Storz Mini Shaver Blades **Indication:** The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ. **Device Description:** The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use instruments. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials of the blades are surgical grade stainless steel. **Substantial Equivalence:** The Karl Storz Multidrive Mini Shaver and blades 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 Multidrive Mini shaver, blades 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:** Renate A. MacLaren, Ph.D. Senior Regulatory Affairs Specialist 000073 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K970055](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K970055) **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