← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K992345 # CHRISTOUDIAS SLIM TIP ELECTRODE INSERT (K992345) _Innervision, Inc. · GEI · Sep 10, 1999 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K992345 ## Device Facts - **Applicant:** Innervision, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Sep 10, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use The Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous. ## Device Story Christoudias Slim Tip Electrode Insert is a surgical instrument used during laparoscopic procedures. Device functions as an electrode to provide coagulation for small bleeding vessels. Operated by surgeons in an operating room setting. Provides targeted thermal energy to achieve hemostasis. Benefits include improved control of bleeding during minimally invasive surgery. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Electrode insert for laparoscopic use. Product code GEI. Class II device. ## 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. ## Related Devices - [K070812](/device/K070812.md) — DISPOSABLE LAPAROSCOPIC INSTRUMENT · Modern Medical Equipment Mfg., Ltd. · Sep 14, 2007 - [K030831](/device/K030831.md) — LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS · Modern Medical Equipment Mfg., Ltd. · Jun 15, 2004 - [K032965](/device/K032965.md) — LAPAROSCOPIC INSTRUMENT, ELECTRODE AND CABLE · Modern Medical Equipment Mfg., Ltd. · May 13, 2004 - [K971674](/device/K971674.md) — VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST · Aaron Medical Industries · Jun 11, 1997 - [K033027](/device/K033027.md) — SHINMED VARIOUS MODELS OF ELECTRO-SURGICAL PENCILS, SW12200, SW12202, SW12300 · Shining World Health Care Co., Ltd. · Aug 12, 2004 ## Submission Summary (Full Text) {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above and below them, creating a sense of movement or connection. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 0 1999 Mr. Frank M. Lewis President InnerVision, Inc. 6258 Shady Grove Road East Memphis, Tennesee 38120 Re: K992345 > Trade Name: Christoudias Slim Tip Electrode Insert Regulatory Class: II Product Code: GEI Dated: June 9, 1999 Received: June 13, 1999 Dear Mr. Lewis: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1}------------------------------------------------ ## Page 2 - Mr. Frank. M. Lewis 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510[K] Number (if known): __ K992 345 Device Name: Christoudias Slim Tip Electrode Insert Indications for Use: The Christoudias Slim Tip Electrode Insert is indicated for laparoscopic surgical procedures where controlling small bleeding vessels with coagulation would be advantageous. ## (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Pcotele (Division Sign-Off) Division of General Restorative Devices K992345 510(k) Number ............................................................................................................................................................................. Prescription Use (Per 21 CFR 801.109) OR Over-the-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K992345](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K992345) **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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