← Product Code [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ) · K960791 # KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS (K960791) _KARL STORZ Endoscopy-America, Inc. · EOQ · Mar 11, 1996 · Ear, Nose, Throat · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K960791 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [EOQ](/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ.md) - **Decision Date:** Mar 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 874.4680 - **Device Class:** Class 2 - **Review Panel:** Ear, Nose, Throat - **Attributes:** Therapeutic, Pediatric ## Intended Use The KSEA Huzly high-frequency cutting loops are designed to remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures. ## Device Story Manually operated, reusable surgical device; consists of bronchoscope tube with cutting loop and high-frequency cord connection. Used in ENT endoscopic procedures; operated by physicians. Device delivers high-frequency electrical current to excise tissue pathologies in bronchi or esophagus. Benefits include precise tissue removal during endoscopic surgery. ## Clinical Evidence Bench testing only. ## Technological Characteristics Materials: surgical grade stainless steel and tungsten. Energy source: high-frequency electrical current. Form factor: bronchoscope tube with cutting loop. Reusable. Manual operation. ## Regulatory Identification A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, 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} STORZ Karl Storz Endoscopy K960791 # 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 Bronchoscopic cutting loop Trade Name Karl Storz Huzly high-frequency cutting loops Indication: The KSEA Huzly high-frequency cutting loops are designed to remove various pathologies of the bronchi and/or esophagus using high-frequency electrical current during ENT endoscopic surgical procedures. Device Description: The KSEA Huzly high-frequency cutting loops are manually operated, reusable surgical devices consisting of a bronchoscope tube with a cutting loop and connection for a high-frequency cord. The Huzly high-frequency cutting loops are available in both adult and pediatric sizes, which are long enough to gain access to the surgical area. The body contact materials are surgical grade stainless steel and tungsten. Substantial Equivalence: The KSEA Huzly high-frequency cutting loops are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same or similar. The differences in features and dimensions between the KSEA Huzly high-frequency cutting loops and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices. Signed: Betty M. Johnson Manager, Regulatory Affairs 000052 --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K960791](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/EOQ/K960791) **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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