Manan Manta Catheter Fixation Disk

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K981229 ↗

FDA Product Code

KNY

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Manan Biliary Drainage Catheter

  Class II

  FDA 510(k) K980191 Active Cleared 9 Feb 1998

• Manan D Bag

  Class II

  FDA 510(k) K980005 Active Cleared 30 Jan 1998

• Ultra-Core Biopsy Needles

  Class I

  FDA 510(k) K921418 Active Cleared 19 Jun 1992

• Techna-Cut Aspiration Needle

  Class II

  FDA 510(k) K974766 Active Cleared 8 Jan 1998

• Pbn Drainage Catheter Guidewires

  Class II

  FDA 510(k) K991097 Active Cleared 23 Apr 1999

• Md Tech Biopsy Set for Bone and Bone Marrow Open recall

  Class II

  FDA 510(k) K980196 Active Cleared 3 Feb 1998

See all devices from Medical Device Technologies, Inc. →

• What is the Manan Manta Catheter Fixation Disk used for?

  The Manan Manta Catheter Fixation Disk is a soft silicone device designed to secure percutaneous drainage catheters to a patient's skin. It is used in gastroenterology and urology procedures to keep drainage catheters properly positioned.

• How is the Manan Manta Catheter Fixation Disk applied?

  The disk is sutured or adhered to the patient's skin, and then the drainage catheter is snapped into the disk and secured using a nylon tie-wrap to maintain proper positioning.

• Is the Manan Manta Catheter Fixation Disk reusable?

  No, the Manan Manta Catheter Fixation Disk is supplied as a single-use device and should not be reused on different patients.

• What is the regulatory status of the Manan Manta Catheter Fixation Disk?

  The device is regulated under FDA 510(k) clearance with product code KNY, meaning it has been determined to be substantially equivalent to existing devices.