Cobe Single-Needle Controller #18-756

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K820173 ↗

FDA Product Code

FIF

Device Class

Class II

Regulation

21 CFR Part 876.5820

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Flowmeter, Optiflo Gas

  Class II

  FDA 510(k) K790546 Active Cleared 11 May 1979

• Cobe Ppd 1.9

  Class II

  FDA 510(k) K812336 Active Cleared 31 Aug 1981

• Cobe Spectra Blood Component Separator Therapeutic

  Unclassified

  FDA 510(k) K900105 Active Cleared 22 Mar 1991

• Cobe Emergency Power Source 43610-000

  Class II

  FDA 510(k) K842138 Active Cleared 3 Aug 1984

• Centry 2 Ultrafiltration Control Kit, #018762-002

  Class II

  FDA 510(k) K881062 Active Cleared 21 Apr 1988

• Cobe Rx Meter

  Class II

  FDA 510(k) K830629 Active Cleared 6 Apr 1983

See all devices from Cobe Laboratories, Inc. →

• What is the Cobe Single-Needle Controller #18-756 used for?

  The Cobe Single-Needle Controller #18-756 is designed for dialysis procedures, specifically to manage controlled fluid exchange through a single-needle system equipped with a unidirectional pump. This makes it particularly useful in specialties like gastroenterology and urology, where precise fluid control is essential for patient safety and procedure success.

• Is the Cobe Single-Needle Controller #18-756 reusable or single-use?

  The Cobe Single-Needle Controller #18-756 is supplied as a reusable medical instrument. Reusability is common for devices intended for controlled clinical environments where proper cleaning, sterilization, and maintenance protocols are followed to ensure safety and functionality across multiple uses.

• What regulatory approval does the Cobe Single-Needle Controller #18-756 hold?

  This device was cleared through an FDA 510(k) submission (K820173) in 1982, with a decision of Substantially Equivalent (SESE) by the Gastroenterology and Urology (GU) Advisory Committee. It falls under FDA Product Code FIF and is classified as a Class II device under regulation number 876.5820.

• Which medical specialties primarily use the Cobe Single-Needle Controller #18-756?

  The device is primarily intended for use in gastroenterology and urology procedures. Its design supports precise fluid management, which is critical in these specialties for procedures requiring controlled dialysis or fluid exchange through a single-needle system.

• Are there any specific storage or handling instructions for the Cobe Single-Needle Controller #18-756?

  The regulatory data does not specify storage or handling instructions for this device. However, standard medical device protocols should be followed to ensure proper maintenance, cleaning, and sterilization when reused. Adhering to these protocols helps prevent contamination and ensures the device remains functional and safe for clinical use.