Tray and Bag, Catheterization

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

510(k) Number

K790271 ↗

FDA Product Code

FCM

Device Class

Class II

Regulation

21 CFR Part 876.5130

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Greenline Irrigation Trays

  Class II

  FDA 510(k) K790607 Active Cleared 11 May 1979

• Yankauer & Poodle Suction Instruments

  Class II

  FDA 510(k) K790419 Active Cleared 23 Apr 1979

• Hemovac Chest Drainage Solution

  Class II

  FDA 510(k) K800861 Active Cleared 2 May 1980

• Surgivac Tm

  Class I

  FDA 510(k) K800578 Active Cleared 16 Apr 1980

• Snyder Hemovac Tm Vented Wound Kit

  Class I

  FDA 510(k) K800577 Active Cleared 16 Apr 1980

• Urinary Drainage Bag (KNX)

  Class II

  FDA 510(k) K790253 Active Cleared 10 Apr 1979

See all devices from Snyder Laboratories, Inc. →

• What is the purpose of the Tray and Bag, Catheterization?

  This device is a sterile urethral catheterization kit designed to assist clinicians in managing the process of patient catheter insertion.

• What components are included in the kit?

  The kit may include a collection bag, lubricant, swabs, gloves, a syringe, and an underpad. It is available for purchase either with or without a catheter included.

• Is this device sterile?

  Yes, the Tray and Bag, Catheterization is provided as a sterile kit to ensure it meets the necessary hygiene standards for urethral catheterization procedures.

• What is the regulatory status of this device?

  The device is classified as a class 2 medical device under 21 CFR 876.5130 and has received FDA 510(k) clearance.