GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C

{0}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image. #### Public Health Service JUN 1 3 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Charles P. Gill Manager, Regulatory Affairs and Quality Assurance Uresil, L.P. 5418 West Touhy Avenue Skokie, IL 60077 Re: K021632 Trade/Device Name: General Purpose Drainage Catheter Regulation Number: 876.5010 and 878.4200 Regulation Name: Biliary catheter and accessories Introduction/drainage catheter and accessories Regulatory Class: II Product Code: GBO Dated: May 3, 2002 Received: May 17, 2002 Dear Mr. Gill: 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 such 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 Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2 - Mr. Charles P. Gill This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html Sincerely yours. Stupt Rhode 1. Witten. Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Attachment 2 ## Indications for Use Statement ## KO21632 510(k) Number Drainage Catheters Indications For Use The UreSil Drainage Catheters are to be used for percutaneous drainage of abscesses, nephrostomies, and other fluids. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use Hyte Purdy (Division Sign-Off) Division of General, Restorative and Neurological Devices KOZI63Z 510(k) Number -