← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K970987 # ELECTROSURGICAL ELECTRODE (K970987) _Fusion Medical Technologies, Inc. · GEI · May 5, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K970987 ## Device Facts - **Applicant:** Fusion Medical Technologies, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** May 5, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface. ## Device Story Fusion Ball Tip Electrode; reusable monopolar electrosurgical accessory. Input: electrical energy from standard electrosurgical generator via electrosurgical pencil/chuck. Operation: delivers high-frequency current to tissue via 99% pure silver ball tip for electrocautery. Used by clinicians in surgical/clinical settings. Output: thermal tissue effect (coagulation/cautery). Benefits: provides large surface area electrocautery; reusable design via autoclave sterilization. ## Clinical Evidence Bench testing only; no clinical data provided. Equivalence based on design, material biocompatibility, and intended use similarity to predicate. ## Technological Characteristics Monopolar electrosurgical electrode. Materials: Stainless steel shank, Polyphenylsulfone insulation, 99% pure silver tip. Dimensions: 3/32 inch (2.4 mm) shaft. Energy: Electrosurgical (RF). Sterilization: Gamma irradiation (initial), autoclave (reusable). Biocompatibility: ISO 10993-1 compliant. ## Regulatory Identification An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current. ## Predicate Devices - Electrosurgical Electrode by Premier Dental Products ([K923332](/device/K923332.md)) ## 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} 046 K970987 510(k) Summary Fusion Medical Technologies, Inc. Ball Tip Electrode MAY - 5 1997 1. Sponsor: Fusion Medical Technologies, Inc. 1615 Plymouth Street Mountain View, CA 94043 Contact Person: Debera Brown Vice President, Regulatory and Clinical Affairs 2. Device Name: Trade Name: To Be Determined Common/Usual Name: Electrosurgical Electrode Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories 3. Identification of the Predicate or Legally Marketed Devices to Which Equivalence is being Claimed: Electrosurgical Electrode by Premier Dental Products 4. Device Description: The Fusion Ball Tip Electrode is a reusable electrode for use in monopolar electrosurgical accessories. 5. Intended Use: Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface. {1} 047 6. A Statement of How the Technological Characteristics of the Device Compare to Those of the Predicate or Legally Marketed Device. | Parameter | Fusion Ball Tip Electrode | Premier Dental Electrode K923332 | | --- | --- | --- | | Indications for Use | Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface. | Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended for cutting and coagulation of tissue. | | Use Profile | Provided Sterile; reusable after cleaning and autoclave sterilization | Provided non-sterile; first use and reuse after autoclave or ETO sterilization | | Compatibility | Standard 3/32 inch (2.4 mm) shaft fits most electrosurgery chucks and pencils | 44 different configurations provided, all standard 3/32 shaft to fit most electrosurgery chucks and pencils | | Material Composition | Stainless Steel shank, Polyphenylsulfone for insulation, 99% Pure Silver as electrode tip | Stainless Steel shank, Korvex 4X Teflon TFE heat shrinkable tubing, Type 304 stainless steel electrode tip | | Sterilization | Provided sterile by gamma irradiation for first use | Provided non-sterile, must be sterilized by user before first use | | Biocompatibility | Materials used in other medical devices; ISO 10993-1 | Materials used in other devices | --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K970987](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K970987) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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