← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K965054 # PENCIL (K965054) _Megadyne Medical Products, Inc. · GEI · Jan 24, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K965054 ## Device Facts - **Applicant:** Megadyne Medical Products, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Jan 24, 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 The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile. ## Device Story Monopolar electrosurgical pencil; molded plastic housing; mode switch for CUT/COAG selection; 10-foot cable with 3-prong plug for generator connection; includes coated or bare electrode; optional holster. Single-use, disposable, sterile. Used in clinical/surgical settings by physicians to deliver electrosurgical energy to target tissue for cutting and coagulation. Benefits include sterile, disposable convenience, reducing cross-contamination risk compared to reusable alternatives. ## Clinical Evidence Bench testing only. Compliance with ANSI/AAMI HF 18-1993. ## Technological Characteristics Molded plastic housing; monopolar electrosurgical pencil; 10-foot cable; 3-prong connector; coated or bare electrodes; single-use; sterile. Complies with ANSI/AAMI HF 18-1993. ## 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 - MegaDyne Medical Products, Inc pencils and electrodes - Valleylab pencils and electrodes - Conmed pencils and electrodes - E&M Engineering pencils ## 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} MEGADYNE 510(k) SUMMARY $k_{96} \leq 0.54$ SAFETY AND EFFECTIVENESS SUMMARY JAN 24 1997 This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. Submitter's Name/Address: Drew D. Weaver Director of Regulatory Affairs MegaDyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax Contact Person: Same as above Date Summary Prepared: December 17, 1996 Device Name: Common Name: Electrosurgical Device, Cutting and Coagulation & Accessories Trade Name: Not yet established Classification (if known): Class II, Tier II, 79GEI, General and Plastic Surgery, 21 CFR 878.4400 MEGADYNE MEDICAL PRODUCTS, INC. • 11506 South State Street • Draper, Utah 84020 • Phone (801) 576-9669 • FAX (801) 576-9698 • Toll Free (800) 747-6110 {1} MegaDyne Medical Products, Inc. 510(k) Notification: Electrosurgical Device, Cutting and Coagulation & Accessories December 11, 1996 Page C.2 ## Predicate Devices: - MegaDyne Medical Products, Inc pencils and electrodes - Valleylab pencils and electrodes - Conmed pencils and electrodes - E&M Engineering pencils ## Applicant Device Description: This device has a molded plastic housing. The mode switch selects the appropriate electrosurgical function (CUT or COAG). Exiting the housing is a ten foot cable which has a standard 3-prong plug to connect to the generator. The electrode packaged with this pencil will be either a coated electrode or a regular bare electrode, and with or without a holster. This device is a single use, disposable. It is sold sterile. ## Applicant Device Intended Use: The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile. ## Technological Characteristics: This device is substantially equivalent in materials and operation to other pencils already on the market. There are no new technological characteristics and therefore no new questions of safety and effectiveness. ## Performance Data: MegaDyne voluntarily complies with ANSI/AAMI HF 18-1993 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K965054](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K965054) **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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