Wsp Code 4315 Padtest

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K850693 ↗

FDA Product Code

FAP

Device Class

Class II

Regulation

21 CFR Part 876.1620

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 WSP Padtest used for?

  The WSP Padtest is used in the field of urology and gastroenterology, specifically for cystometric gas procedures.

• Is the WSP Padtest a single-use or reusable device?

  The device data does not specify whether the WSP Padtest is single-use or reusable, but it is classified as a class 2 device with a specific product code and regulation number.

• What is the regulatory status of the WSP Padtest?

  The WSP Padtest has an FDA 510K authorization and is classified as substantially equivalent, with a review by the Gastroenterology and Urology advisory committee.

• What are the specifications of the WSP Padtest?

  The WSP Padtest has a product code of FAP, a regulation number of 876.1620, and multiple registration and FEI numbers associated with it, indicating its classification and use in medical specialties.