← Product Code [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI) · K955650 # OLYMPUS SD SERIES SNARES (K955650) _Olympus America, Inc. · FDI · Mar 29, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K955650 ## Device Facts - **Applicant:** Olympus America, Inc. - **Product Code:** [FDI](/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI.md) - **Decision Date:** Mar 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4300 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract. ## Device Story Reusable electrosurgical snare; used for endoscopic tissue resection in GI tract. Components: proximal control handle, electrical connection cord (A-cord), flexible catheter tube, distal snare loop. Operation: physician positions snare loop around target tissue via slider on control handle; tissue resected via mechanical strangulation combined with electrosurgical current from external generator. Used in clinical/endoscopy settings. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Reusable electrosurgical snare; consists of control handle, A-cord, flexible catheter, and wire loop. Energy source: external electrosurgical generator. Materials: standard medical-grade components for endoscopic use. Sterilization: reusable design requiring standard reprocessing protocols. ## Regulatory Identification An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator. ## Predicate Devices - Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares - Olympus SD-14/15 sterile disposable snares ## 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} K955650 # 510(k) Summary for Olympus SD Series of Reusable Electrosurgical snares Device Name: Olympus SD snares MAR 29 1996 Common/Usual Name: Snares Classification Name: Endoscope Electrosurgical Unit and Accessories 21 CFR 876.4300 Predicate Devices: Olympus SD-1/2/3/4/5/6 pre-Amendment electrosurgical snares and Olympus SD-14/15 sterile disposable snares. Contact Person: Barry Sands Olympus America, Inc. Medical Instrument Division 2 Corporate Center Drive Melville, NY 11747-3157 (516) 844-5474 Summary Preparation Date: November 10, 1995 Summary Revision Date: February 27, 1996 Statement of Intended Use: The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract. Device Description: The SD series of snares and the predicated snares are all designed to endoscopically resect tissue from within the GI tract. The SD snares consist of a proximal end control handle, an electrical connection cord (A-cord), a flexible catheter-like tube, and a distal end snare loop. The detachable control handle contains the electrical connections which permit the snare loop to be connected to an electrosurgical generator via the A-cord. The distal end snare loop may be positioned around the target tissue by movement of a slider on the control handle. The tissue is resected by a combination of mechanical strangulation and electrosurgical current. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K955650](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FDI/K955650) **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