(30 days)
This catheter/stent is intended for use when the physician selects a patient suitable for percutaneous drainage from the ureterpelvic junction to the bladder while maintaining external access.
Modified Uresil® Nephro-Ureteral Stent
This document is a 510(k) clearance letter from the FDA for a medical device called the "Uresil® Nephro-Ureteral Stent" (K980889). It declares the device substantially equivalent to pre-amendment devices or reclassified devices.
This type of document (510(k) clearance) does not include information about specific acceptance criteria or studies proving device performance in the way a clinical trial report or a performance study summary for an AI/ML powered device would.
The FDA 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on proving novel performance metrics or conducting extensive new clinical studies unless the device represents a significant technological change.
Therefore, I cannot provide the requested information from this document. The document primarily discusses regulatory classification and marketing authorization based on substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 1998
Mr. Lev Melinyshyn Director of Operations UreSil, L.P. 5418 W. Touhy Avenue Skokie, Illinois 60077
Re: K980889 Uresil® Nephro-Ureteral Stent Dated: February 27, 1998 Received: March 9, 1998 Regulatory Class: Unclassified Product Code: 78 LJE
Dear Mr. Melinyshyn:
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 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 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Provisions, or other Federal laws or regulations.
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) 594-4613. 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 vours.
K. William Chen
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
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ATTACHMENT C
Page 1 of 1
510(k) Number (if known): unknown
Device Name: Modified Uresil® Nephro-Ureteral Stent
Indications For Use:
. . .
This catheter/stent is intended for use when the physician selects a patient suitable for percutaneous drainage from the ureterpelvic junction to the bladder while maintaining external access.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| (Division Sign(Off)) | for RRG |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K980889 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---------------------------- | ----------------------------------------------- |
f/n: intenus
N/A