← Product Code [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI) · K022593 # THOMAS MEDICAL ELECTRODES (K022593) _Thomas Medical, Inc. · HGI · Nov 1, 2002 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K022593 ## Device Facts - **Applicant:** Thomas Medical, Inc. - **Product Code:** [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI.md) - **Decision Date:** Nov 1, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.4120 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for Use To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc. ## Device Story Thomas Medical Electrodes are surgical accessories used for electrosurgical procedures. The device functions by delivering electrical energy to soft tissue to perform cutting and coagulation. It is intended for use by clinicians in a medical setting for gynecological and dermatological applications, specifically targeting the uterine cervix and various skin lesions. The device acts as an interface between an electrosurgical generator and the patient's tissue, allowing the physician to precisely excise or coagulate tissue during surgical interventions. This facilitates the removal of lesions and management of tissue conditions, providing a therapeutic benefit through controlled electrosurgical destruction or excision. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Electrosurgical electrode accessory for use with electrosurgical generators. Designed for soft tissue cutting and coagulation. Form factor consists of conductive tips for tissue contact. Operates via electrical energy transfer. No software or complex electronic components described. ## Regulatory Identification A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables. ## 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}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a common symbol associated with healthcare and medicine. The text "Department of Health" is arranged around the caduceus. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 2002 Re: K022593 Mr. Thomas J. Zinnanti President and CEO Thomas Medical, Inc. 4100-C Nine McFarland Drive ALPHARETTA GA 30004 Trade/Device Name: Thomas Medical Electrodes Regulation Number: 21 CFR 884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: 85 HGI Dated: July 30, 2002 Received: August 5, 2002 Dear Mr. Zinnanti: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Par: 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Aet); 21 CFR 1000-1050, {1}------------------------------------------------ This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html. Sincerely yours. Nancy C. Snogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Section #4 ... : : Indications for Use | 510(k) Number: | K022593 (to be assigned) | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | Thomas Medical Electrodes | | Intended Use: | To be used for soft tissue cutting of the uterine cervix and coagulation, intraepithelial neoplasia, condylomata acuminata, and miscellaneous lesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc. | : : Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use |
✓
| |-------------------|--------------------------------------------------------------------------| | (Per CFR 801.109) | | OR | Over-the-counter use | ____________________ | |----------------------|----------------------| |----------------------|----------------------| | (Division Sign-Off) | | |---------------------------------------------------------------|--| | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | | Page 5 of、バ Page 5 of 17 . --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K022593](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K022593) **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