Suction Irrigator

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

510(k) Number

K003443 ↗

FDA Product Code

FHF

Device Class

Class II

Regulation

21 CFR Part 876.4370

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Expanding Vascular Sheath

  Class II

  FDA 510(k) K070865 Active Cleared 23 Oct 2007

• Applied Gauze Sponge 4X4X16 Ply

  Unclassified

  FDA 510(k) K844673 Active Cleared 1 Apr 1985

• Flexible Occlusion System

  Class II

  FDA 510(k) K002915 Active Cleared 8 Jan 2001

• Applied Gauze Sponge 3X3X12

  Unclassified

  FDA 510(k) K844675 Active Cleared 1 Apr 1985

• Epix Irrigation Pump, Epix Suction Irrigation Tubing Set

  Class II

  FDA 510(k) K122619 Active Cleared 2 Oct 2012

• Surgical Trocar

  Class II

  FDA 510(k) K911462 Active Cleared 22 Apr 1991

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• What is the suction irrigator used for?

  The suction irrigator is designed for the evacuation and irrigation of fluids during surgical procedures, specifically to maintain a clear operative field in laparoscopic surgery by combining suction and irrigation functions in a single system.

• How is the suction irrigator supplied and is it sterile?

  The device is supplied as a disposable tubing set and is non-sterile unless otherwise specified, meaning it requires sterilization by the user before use if sterility is required for the procedure.

• Can the suction irrigator be reused after a procedure?

  No, the suction irrigator is intended for single-use only, as indicated in the device description, to prevent cross-contamination and ensure reliable performance during laparoscopic fluid management.

• What regulatory clearance does the suction irrigator have?

  The suction irrigator is authorized under FDA 510(k) clearance with K-number K003443, classified as a Class II medical device with product code FHF, and was determined to be substantially equivalent to a predicate device.