Curity(R) Calib Tuohy Type Epidur Needle Fix Wing

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

510(k) Number

K910791 ↗

FDA Product Code

BSP

Device Class

Class II

Regulation

21 CFR Part 868.5150

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Curity Vented Dressing System

  Unclassified

  FDA 510(k) K915635 Active Cleared 31 Jan 1992

• Kendall Safetrak Combined Epidural/Spinal Kit

  Class II

  FDA 510(k) K941493 Active Cleared 22 Jun 1994

• Kendall Universal Extension Set

  Class I

  FDA 510(k) K930551 Active Cleared 12 May 1993

• Kendall Home Rx Therapeutic Stocking

  Class II

  FDA 510(k) K925417 Active Cleared 4 Jun 1993

• Curad Kid Size Instant Cold Pack

  Class I

  FDA 510(k) K920252 Active Cleared 11 Feb 1992

• Curity Pediatric Continuous Caudal Anesthesia Tray

  Class II

  FDA 510(k) K902647 Active Cleared 29 Nov 1990

See all devices from Kendall Healthcare Products Co. Div.Of Tyco Health →

• What clinical setting is the Curity Calib Tuohy Type Epidural Needle Fix Wing intended for, and why is this important?

  The Curity Calib Tuohy Type Epidural Needle Fix Wing is designed for use in sterile environments like operating rooms and procedural suites, where precise placement of anesthetic agents into the epidural space is required. This setting ensures sterility and precision are maintained, which are critical for safe and effective epidural anesthesia procedures.

• Is the Curity Calib Tuohy Type Epidural Needle Fix Wing intended for single-use or reuse, and how does this affect its handling?

  The device is explicitly intended for single-use only, meaning it should not be reused after a single procedure. This design choice ensures patient safety by preventing cross-contamination and maintaining sterility, which is essential for procedures involving direct access to the epidural space.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical practice?

  The Curity Calib Tuohy Type Epidural Needle Fix Wing received FDA 510(k) clearance (K910791) under the Traditional 510(k) pathway, demonstrating it was deemed substantially equivalent to a predicate device already on the market. This means it has undergone FDA review for safety and effectiveness, allowing clinicians to use it with confidence in procedures requiring epidural anesthesia.

• How is the device supplied, and what should clinicians consider when storing it?

  The Curity Calib Tuohy Type Epidural Needle Fix Wing is supplied sterile and packaged for single-use. Clinicians should store it in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and functionality until use. Proper storage ensures the device remains uncontaminated and ready for sterile procedural environments.