Urologic Tube Holder

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

510(k) Number

K810787 ↗

FDA Product Code

OCV

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Surgical Tube Holder

  Class I

  FDA 510(k) K810788 Active Cleared 17 Apr 1981

• Coverups

  Class I

  FDA 510(k) K831703 Active Cleared 3 Jan 1984

• Cover-All Male Incontinence Device

  Class II

  FDA 510(k) K801629 Active Cleared 12 Aug 1980

• Suction Wound Drainage Device

  Class II

  FDA 510(k) K810739 Active Cleared 26 Jun 1981

• Surgical Tube Holder

  Class II

  FDA 510(k) K831489 Active Cleared 12 Dec 1983

• What is the primary function of the Urologic Tube Holder?

  This device is designed to serve as an endoscope holder that provides a stable attachment point for catheters and medical tubing. By securing these tubes, it ensures they remain in the correct position throughout the duration of a clinical procedure.

• What is the regulatory status of this device?

  The Urologic Tube Holder is regulated under FDA 510(k) clearance number K810787. It is classified as a class 2 medical device under regulation number 876.1500, which pertains to endoscope holders used in gastroenterology and urology.

• Which medical specialties use this tube holder?

  The device is intended for use within the fields of gastroenterology and urology. It is categorized under the GU advisory committee, reflecting its application in procedures requiring the secure management of endoscopic or catheter-based tubing.