Sterile Polyhesive PBS Dressing

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

510(k) Number

K890021 ↗

FDA Product Code

KGF

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SN

• Models E2502B/E2525 Reusable Handswitching Pencils

  Class II

  FDA 510(k) K914400 Active Cleared 17 Oct 1991

• Cusa System 200C, T & M Ultrasonic Surgical Aspira.

  Unclassified

  FDA 510(k) K884412 Active Cleared 2 Dec 1988

• Valleylab Procision(Tm) System

  Class II

  FDA 510(k) K945688 Active Cleared 13 Jun 1995

• Ligasure 5mm Blunt Tip Laparoscopic Sealer-Divider

  Class II

  FDA 510(k) K092879 Active Cleared 16 Oct 2009

• Davis Bayonet Electrodes

  Class II

  FDA 510(k) K964602 Active Cleared 9 Jan 1997

• Force Gsu System Model No. Gsu-20 and Gsu-22

  Class II

  FDA 510(k) K942579 Active Cleared 21 Sep 1994

See all devices from Valleylab, Inc. →

• What types of surgical procedures is this dressing specifically intended to support during aneurysm repair?

  The Sterile Polyhesive PBS Dressing is designed to provide secure adhesion for surgical applications involving aneurysm repair, particularly to maintain wound integrity and promote healing in vascular procedures. Its adhesive properties help stabilize the surgical site, which is critical in aneurysmorrhaphy (suturing of an aneurysm) to prevent complications like dehiscence or infection.

• Is this dressing reusable, or is it meant to be used only once per patient?

  This dressing is explicitly intended for single-use only, as indicated by its FDA 510(k) clearance (K890021) and classification as a sterile, disposable medical device. Reusing it could compromise sterility and compromise patient safety, so it should not be reused after a single application.

• How should I store this dressing before use, and what are the implications of improper storage?

  The Sterile Polyhesive PBS Dressing is supplied sterile, so it must be stored in its original packaging until ready for use to preserve sterility. Exposure to moisture, contamination, or extreme temperatures could compromise its integrity. Always check the packaging for tears or damage before opening, and avoid storing it in areas with high humidity or direct sunlight.

• What regulatory pathway was followed for this device’s clearance, and when was it originally approved?

  The Sterile Polyhesive PBS Dressing was cleared through the FDA’s traditional 510(k) pathway under clearance number K890021, with a decision date of June 1, 1989. It was determined to be *substantially equivalent* for some indications to a legally marketed predicate device, falling under Class 3 regulatory classification. This means it underwent rigorous review to ensure safety and effectiveness for its intended surgical use.