URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S

K972583 · Uresil Corp. · FGE · Aug 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972583
• Device Name: URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
• Applicant: Uresil Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For percutaneous drainage of abscess, nephrostomy and other fluids.

Device Story

Uresil Percutaneous Drainage Catheters are medical devices designed for the percutaneous drainage of abscesses, nephrostomy, and other fluid collections. The device is used by clinicians in a clinical setting to facilitate the removal of fluids from the body. It functions as a conduit for drainage, allowing for the therapeutic management of fluid accumulations. The catheter is inserted percutaneously, providing a minimally invasive approach to drainage, which can benefit patients by reducing the need for more invasive surgical procedures. The healthcare provider uses the device to manage fluid collections, directly impacting clinical decision-making regarding patient drainage needs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous drainage catheter; materials and dimensions consistent with standard drainage catheter designs; non-powered, mechanical device.

Indications for Use

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

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 1997

Mr. Lev Melinyshyn Director of Operations Uresil, L.P. 5418 W. Touhy Avenue Skokie, Illinois 60077 ... Re: K972583 Uresil® Percutaneous Drainage Catheters Dated: June 24, 1997 Received: July 10, 1997 Regulatory class: II, and unclassified ... ... 21 CFR §876.5010/Product code: 78 FGE 21 CFR §878.4200/Product codes: 79 GBO, 79 GBX 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 (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 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 submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 marked 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 question 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/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

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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## INDICATIONS FOR USE | | | | Page 1 of 5

## 510(k) Number: K972583

Device Name: Uresil General Purpose Drainage Catheters

Indications for Use:

For percutaneous drainage of abscess, nephrostomy and other fluids.

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f/n: indusc02

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert P. Satling
(Division Sign Off)

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

Prescription Use
(Per 21 CFR 801.109)

OR

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