HuberLoc

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

510(k) Number

K973497 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Biopsy Tray

  Class II

  FDA 510(k) K970152 Active Cleared 5 Mar 1997

• Medcare Tracheostomy Care Tray

  Class I

  FDA 510(k) K961167 Active Cleared 2 Jul 1996

• Catheter Insertion Tray

  Class II

  FDA 510(k) K962849 Active Cleared 7 Oct 1996

• Medcare Regional Anethesia Kit

  Class II

  FDA 510(k) K961075 Active Cleared 6 Sep 1996

• Single Use Instrument Tray

  Class I

  FDA 510(k) K962328 Active Cleared 9 Aug 1996

• Medcare Suction Connecting Tubing

  Class II

  FDA 510(k) K961880 Active Cleared 19 Jul 1996

See all devices from Medcare Medical Group, Inc. →

• What is the HuberLoc designed to do during the removal of implanted ports or catheters?

  The HuberLoc is specifically engineered to secure needle removal and containment when accessing subcutaneous or intravascular implanted ports and catheters. Its primary purpose is to prevent accidental needle sticks and reduce contamination risks, thereby enhancing patient safety during these procedures.

• Is the HuberLoc intended for reuse or is it meant to be used only once?

  The HuberLoc is supplied as a single-use device, meaning it is intended for one-time use only. This design ensures sterility and reduces the risk of cross-contamination between patients.

• What types of medical settings is the HuberLoc approved for use in?

  The HuberLoc is intended for use in general hospital settings, as indicated by its classification under 21 CFR 880.5965 and its advisory committee designation for general hospitals.

• How is the HuberLoc supplied, and is it sterile?

  The HuberLoc is supplied as a sterile, single-use product, ensuring it meets medical-grade hygiene standards for direct patient use in clinical procedures.

• What regulatory pathway was followed for the FDA clearance of the HuberLoc?

  The HuberLoc received FDA 510(k) clearance (K973497) through the traditional review pathway, demonstrating it is substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. medical device regulations for safety and performance.