MANAN

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

510(k) Number

K974743 ↗

FDA Product Code

DRC

Device Class

Class II

Regulation

21 CFR Part 870.1390

Advisory Committee

Cardiovascular

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 trocar used for in surgical procedures?

  The MANAN is a trocar designed to create an initial entry point for accessing body cavities during surgical procedures, allowing other instruments to be inserted.

• Is the MANAN trocar single-use or reusable?

  The device description does not specify whether the MANAN trocar is intended for single-use or reuse, so users should consult the manufacturer's instructions for proper handling and disposal.

• What regulatory status does the MANAN trocar have?

  The MANAN trocar has FDA 510(k) clearance with product code DRC, making it a Class II medical device that is substantially equivalent to other devices on the market.

• What information is available about the MANAN trocar's sterility and storage?

  The device description does not provide specific information regarding sterility status, MRI safety, or storage conditions, so users should refer to the manufacturer's documentation for these details.