URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING

K981344 · Uresil Corp. · LJE · Sep 10, 1998 · GU

Device Facts

• Record ID: K981344
• Device Name: URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
• Applicant: Uresil Corp.
• Product Code: LJE · GU
• Decision Date: Sep 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

For percutaneous drainage of abscess, nephrostomy and other fluids.

Device Story

Uresil General Purpose Drainage Catheter facilitates percutaneous drainage of abscesses, nephrostomy, and other fluid collections. Device features hydrophilic coating to reduce friction during insertion. Used by clinicians in clinical settings for minimally invasive fluid management. Catheter is inserted percutaneously to provide a pathway for fluid evacuation, aiding in patient recovery and symptom relief.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous drainage catheter with hydrophilic coating. Materials and dimensions are consistent with standard drainage catheter designs. Sterilization method not specified.

Indications for Use

Indicated for percutaneous drainage of abscesses, nephrostomy, and other fluid collections in patients requiring such drainage.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

Mr. Lev Melinyshyn Director of Operations Uresil, L.P. 5418 W. Touhy Avenue Skokie, IL 60077

Re: K981344

Uresil® Percutaneous Drainage Catheters with Hydrophilic Coating Dated: July 24, 1998 Received: July 29, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 FGE 21 CFR 878.4200/Procodes: 79 GBO, 79 GBX Unclassified/Procode: 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 (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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 submission does not affect any obligation you might have under sections 542 of 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 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrbdsmamain.html".

Sincerely your

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

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## ATTACHMENT D

Page 1 of 5

510(k) Number (if known): unknown

Device Name: Uresil General Purpose Drainage Catheter

Indications For Use:

For percutaneous drainage of abscess, nephrostomy and other fluids.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

f/n: intenus

David L. Ayres

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number .