STRYKER URETEROSCOPE

{0}------------------------------------------------ ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Ko 43021 ## Device Name | Proprietary Name: | Stryker Ureteroscope | |------------------------|--------------------------------------------------| | Common and Usual Name: | Endoscope, Ureteroscope, Semi-Rigid Ureteroscope | | Classification Name: | Ureteroscope | This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of the SMDA 1990. The Stryker Ureteroscope is substantially equivalent in tems of safety and effectiveness The Stryker Oreler Orelerooope is SESSMANANT as a surfield The Stryker Ureteroscope is a new product developed by Stryker. The Stryker The Stryter Offectionscope is a now product as a now product and polymers. The Stryker Ureteroscope is indicated for use during minimally invasive urological surgical surgical surgical to The Stryker Oreleroscope is Inclied for access and is intended for, but not limited to, procedures accessed through hatural betty and, utilizing additional accessories, to perform various diagnostic and therapeutic procedures. The Stryker Ureteroscope conforms to the following voluntary safety and performance The Stryker Orelerssope conforms to the rollering relieve of Endoscopic Equipment, ISO 10993 Biological Evaluation of Medical Devices. There are no significant technological or performance differences between the Stryker Ureteroscope and the identified predicate device, nor are there any new questions raised Ureteroscope and the luentified produce the Stryker Ureteroscope is substantially equivalent to the identified predicate device. Contact: Catrick 11/1/04 Christopher L. Cook Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2288 408-754-2521 Fax: Email: chris.cook@stryker.com {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of an eagle with three wavy lines extending from its body. The logo is black and white and appears to be of a government organization. MAR 1 6 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Christopher L. Cook Regulatory Supervisor Stryker Endoscopy 5900 Optical Court SAN JOSE CA 95138 Re: K043021 Trade/Device Name: Stryker Ureteroscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 FGB Dated: February 18, 2005 Received: February 22, 2005 Dear Mr. Cook: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your bottler been is substantially equivalent (for the indications for use stated in above and have deceally marketed predicate devices marketed in interstate commerce prior to the cholosate) to regary mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the classified in the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in aboordal of a premarket approval application (PMA). You may, therefore, market the do not require approval or of a provisions of the Act. The general controls provisions of the Act ut fice, subjoct to the general 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 n your device is onastilized to such additional controls. Existing major regulations affecting your Applovary, it they of bely 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 I lease oc advirod that i Dr. I be rice complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the I carrat statues and regulations as and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 8077, good 800); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device of your device to a legally premarket notification. The FDA inding of substantial organisations of the 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 If you desire specific advice for your device on our laboring regarmers. contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Wisonation on your responsibilities under the Act from the 180 807.97). You may obtain other general information on your replainter at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Device Name: Stryker Ureteroscope K04 3021 Indications for Use: The Stryker Ureteroscope is indicated for use during minimally invasive urological surgical The Stryker Ureleroscope is indical body offices, and is intended for, but not linked to, procedures accessed through thatural bouy offices, and, utilizing additional accessories, to perform transurethral examination of the unnactures transarothar and therapeutic procedures. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David h. Symm (Division Sign Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Prescription Use Use (Per 21 CFR 801.109) OR Over-The-Counter-