Sterile Suction Tubing Set

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

510(k) Number

K901761 ↗

FDA Product Code

BYY

Device Class

Class II

Regulation

21 CFR Part 880.6740

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Prefilled Syringe for Inflation of Foley Catheter

  Class II

  FDA 510(k) K952414 Active Cleared 23 Jun 1995

• Sterigauze Gel Dressing

  Unclassified

  FDA 510(k) K952419 Active Cleared 26 Jul 1995

• Horizon Foley Catheterization Tray Without Catheter

  Class II

  FDA 510(k) K950344 Active Cleared 24 Mar 1995

• Newmark(Tm) Coronary Artery Bypass Graft Markers

  Class I

  FDA 510(k) K892856 Active Cleared 8 Nov 1989

• Hydracare Absorbent Wound Dressing

  Class I

  FDA 510(k) K951914 Active Cleared 15 May 1995

• Surgi-Tag(Tm) Sterile Label Sets

  Class I

  FDA 510(k) K884055 Active Cleared 13 Oct 1988

See all devices from Acacia Laboratories, Inc. →

• What is the Sterile Suction Tubing Set used for?

  The Sterile Suction Tubing Set is designed for suction applications in clinical settings, facilitating the removal of fluids or air during medical procedures.

• Is the Sterile Suction Tubing Set reusable?

  No, this device is supplied in a sterile condition and is intended for single-use only. It should not be reused for any medical procedure.

• What are the regulatory specifications for this device?

  The Sterile Suction Tubing Set is authorized under FDA 510K clearance with product code BYY and model number K901761. It was determined to be substantially equivalent to predicate devices.

• Is the Sterile Suction Tubing Set MRI compatible?

  The device is not specified as MRI compatible. Users should verify compatibility requirements before use in MRI environments.