← Product Code [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX) · K963029 # KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE (K963029) _KARL STORZ Endoscopy-America, Inc. · HRX · Nov 27, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K963029 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [HRX](/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX.md) - **Decision Date:** Nov 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.1100 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMJ), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff. ## Device Story Sterile, single-use surgical arthroscopic blade; accessory to arthroscopes. Used by surgeons in clinical settings for controlled tissue shaving, abrading, debridement, or cutting during arthroscopic procedures. Mechanical operation; blade geometry facilitates access to joint spaces. Enables precise tissue removal/smoothing; aids in joint repair and debridement. Benefits patient through minimally invasive surgical access and effective tissue management. ## Clinical Evidence Bench testing only. ## Technological Characteristics Surgical grade stainless steel construction; sterile, single-use; mechanical cutting/abrading blade; accessory to arthroscopes. ## 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} 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 NOV 27 1996 k963029 # 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 Surgical Arthroscopic Blade Trade Name Karl Storz Slotted Whisker Arthroscopic Blade Indication: The KSEA Slotted Whisker Arthroscopic Blade is designed to provide controlled shaving, abrading, debridement or cutting of tissue during arthroscopic surgical procedures in both large joints (shoulder, hip, and knee) and small joints (elbow, wrist, ankle and TMJ), including debridement in patellar chondromalacia and smoothing of meniscal edges, the glenoid labrum, or rotator cuff. Device Description: The KSEA Slotted Whisker Arthroscopic Blade is sold as a sterile, single use device. The blade is long enough to gain access to the surgical area and is designed to be used as an accessory to arthroscopes. The body contact materials of the blades are surgical grade stainless steel. Substantial Equivalence: The KSEA Slotted Whisker Arthroscopic Blade 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 Slotted Whisker Arthroscopic Blade 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 000035 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K963029](https://fda.innolitics.com/submissions/OR/subpart-b%E2%80%94diagnostic-devices/HRX/K963029) **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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