Suction Wound Drainage Device

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

510(k) Number

K810739 ↗

FDA Product Code

KQT

Device Class

Class II

Regulation

21 CFR Part 876.4370

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

• Urologic Tube Holder

  Class II

  FDA 510(k) K810787 Active Cleared 31 Mar 1981

• Surgical Tube Holder

  Class II

  FDA 510(k) K831489 Active Cleared 12 Dec 1983

• What specialties is this suction wound drainage device intended for, and how does that affect its use in clinical settings?

  This device is specifically classified under the Gastroenterology and Urology specialties, as noted in its regulatory categorization (product code KQT). While it is designed for wound drainage and fluid removal in surgical sites, its intended use is limited to these specialties. Clinicians should confirm its suitability for their procedure type before use, as it is not approved for chest drainage and must align with manufacturer instructions to prevent complications.

• Is this device reusable, or is it meant for single-use only? How does that impact its handling and disposal?

  The device is explicitly intended for single-use only, as stated in the manufacturer’s instructions. This means it should not be cleaned, reprocessed, or reused after a single procedure to maintain sterility and safety. Clinicians must adhere to proper disposal protocols for single-use medical devices to comply with regulatory and infection control standards.

• How is this suction wound drainage device supplied, and what should clinicians check before using it?

  The device is supplied sterile and ready for immediate use, as required by its FDA 510(k) clearance. Before use, clinicians should verify the sterility seal is intact, check for any visible damage or contamination, and ensure the device matches the intended procedure (e.g., gastroenterology or urology). Always follow the manufacturer’s instructions for setup and application to avoid complications.

• What regulatory pathway was followed for this device’s approval, and how does that affect its use in the U.S.?

  This device received FDA 510(k) clearance (K810739) under the Traditional pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. This clearance confirms it meets FDA safety and effectiveness standards for its intended use in wound drainage and fluid removal in gastroenterology and urology procedures. Clinicians can rely on this approval for its designated applications, but it should not be used off-label or for unrelated procedures.