ELECTRODES/PROBES/DEVICES

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 7 1998 Mr. Ashvin Desai President Ximed Medical/ProSurg, Inc. 2195 Trade Zone Boulevard San Jose. California 95131 Re: K974637 Electrodes/Probes/Devices Dated: December 1, 1997 Received: December 12, 1997 Regulatory class: II 21 CFR 8876.4300/Product code: 78 FAS 21 CFR §876.1500/Product code: 78 FDC Dear Mr. Desai: We have reviewed your Section 510(k) notification of intent to market the device 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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore; 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 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 (QS) 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 conceming 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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) 594-4613. Additionally, for question 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. William Yu Lillian Yin, Ph.D. Director. Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {1}------------------------------------------------ 510(k) NUMBER (IF KNOWN): DEVICE NAME : Electrodes/Probes/Devices INDICATIONS FOR USE: The electrosurgical probes and devices are to be used with commercially available R.F. generators, endoscopes including hysteroscopes, resectoscopes, cystoscopes and laparoscopes, suction/irrigation systems. These devices can be used for laparoscopic, hysteroscopic, cystoscopic, resectoscopic and other endoscopic and open surgical procedures including TURP, BPH, prostate surgery, and other soft tissue removal using cutting/coagulation/ablation mode of R.F. energy. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <div style="text-align:right;">OR</div> | |----------------------|-----------------------------------------| | (Per 21 CFR 801.109) | | --- Carolyn Y Neuland for LLY --- | (Division Sign-Off) | | |-------------------------------------------|---------| | Division of Reproductive, Abdominal, ENT, | | | and Radiological Devices | | | 510(k) Number | K974637 | Over - The - Counter - Use (Optional Format 1-2-96)