Suture Removal Trays

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

510(k) Number

K943090 ↗

FDA Product Code

FRG

Device Class

Class II

Regulation

21 CFR Part 880.6850

Advisory Committee

General Hospital

FDA Decision

SEKD

• Dental Hygiene Tray

  Class I

  FDA 510(k) K944139 Active Cleared 15 Dec 1994

• Dentist with Assistant Pack

  Class I

  FDA 510(k) K940864 Active Cleared 2 Aug 1994

• Radiology Packs

  Class II

  FDA 510(k) K952539 Active Cleared 14 Jul 1995

• Skin Staple Removal Trays

  Class I

  FDA 510(k) K943046 Active Cleared 29 Jul 1994

• General and Plastic Surgery Packs

  Class II

  FDA 510(k) K951478 Active Cleared 13 Jun 1995

• IV Start Kits

  Class I

  FDA 510(k) K943047 Active Cleared 14 Sep 1994

See all devices from Sterile Concepts, Inc. →

• Are these suture removal trays reusable or designed for single-use only, and why does that matter for my clinical workflow?

  These suture removal trays are explicitly designed for single-use only, as stated in the manufacturer’s instructions. This ensures sterility and reduces the risk of cross-contamination between patients, which is critical in wound care procedures. Since they come sterile and include precision tools like scissors and forceps, reusing them could compromise their sterility and potentially introduce infection risks, making single-use the safest and most practical choice for your workflow.

• What tools and supplies are included in the suture removal trays, and how do they help during the procedure?

  Each tray includes precision scissors and forceps for precise suture removal, along with sterile gauze to manage the wound site during the procedure. These tools are specifically designed to minimize tissue trauma while removing sutures, and the gauze helps maintain a clean, controlled environment during the process, reducing the risk of infection or further irritation.

• How should I store these trays before use to ensure they remain effective and sterile?

  The trays must be stored in a clean, dry environment prior to use, as specified by the manufacturer. This prevents moisture damage, dust contamination, or degradation of the sterile barrier packaging. Proper storage ensures the tools and gauze remain in optimal condition for safe, single-use application in your clinical setting.

• What is the regulatory pathway for these suture removal trays, and how does that affect their use in hospitals?

  These trays were cleared via an FDA 510(k) submission (K943090) under the product code FRG, which categorizes them for general surgical use in hospital settings. This clearance confirms they meet FDA safety and performance standards for their intended single-use purpose, giving clinicians confidence in their reliability and compliance with regulatory requirements.