Secure W/25MM Diam. Sheath & Adhesive

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

510(k) Number

K840702 ↗

FDA Product Code

KNX

Device Class

Class II

Regulation

21 CFR Part 876.5250

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Rolled Neck W/Plug

  Class I

  FDA 510(k) K841411 Active Cleared 18 Apr 1984

• Crystalcone Face Mask-Med-W/Hookring

  Class I

  FDA 510(k) K834536 Active Cleared 25 Jan 1984

• Bush Neck W/Tap

  Class II

  FDA 510(k) K841410 Active Cleared 18 Apr 1984

• Wsp Code 4301 Diomaster Therapeutic

  Class II

  FDA 510(k) K850695 Active Cleared 16 May 1985

• Rolled Neck W/Tap

  Class I

  FDA 510(k) K841412 Active Cleared 18 Apr 1984

• Bush Neck W/Plug

  Class II

  FDA 510(k) K841409 Active Cleared 18 Apr 1984

See all devices from Warne Surgical Products, Ltd. →

• What is the SECURE W/25MM DIAM. SHEATH & ADHESIVE used for?

  The SECURE W/25MM DIAM. SHEATH & ADHESIVE is a collector designed for urine collection from patients with indwelling catheters, specifically used in urology and gastroenterology procedures.

• Is this device reusable or single-use?

  The SECURE W/25MM DIAM. SHEATH & ADHESIVE is intended for single-use only and should not be reused according to the manufacturer's instructions.

• What are the specifications of the SECURE W/25MM DIAM. SHEATH & ADHESIVE?

  This device features a 25mm diameter sheath with an adhesive component and is classified as a Class 2 medical device with FDA 510(k) clearance K840702, granted on March 22, 1984.

• How should the SECURE W/25MM DIAM. SHEATH & ADHESIVE be stored?

  The device should be stored according to the manufacturer's instructions, though specific storage conditions are not detailed in the provided information.