Sensi-Touch Epidural Anesthesia Tray

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

510(k) Number

K950929 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESK Substantially Equivalent — Kit

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See all devices from Sherwood Medical Co. →

• What types of components are included in the Sensi-Touch Epidural Anesthesia Tray, and how does it improve procedural efficiency?

  The Sensi-Touch Epidural Anesthesia Tray is designed as an organized assembly of essential components for epidural anesthesia procedures, including needles, catheters, and related instrumentation. Its structured layout ensures all tools are aligned and easily accessible, which helps streamline workflow, reduce setup time, and minimize the risk of misplacement or contamination during procedures.

• Is the Sensi-Touch Epidural Anesthesia Tray compatible with MRI environments, and what precautions should be taken?

  Yes, the tray is compatible with standard MRI environments, but facilities should verify specific MRI safety protocols before use. While the device itself is designed to be MRI-safe, individual components (e.g., metallic instruments) may still require assessment to avoid interference or safety hazards during imaging.

• How should the Sensi-Touch Epidural Anesthesia Tray be stored, and is it reusable?

  The tray is intended for single-use only and is supplied sterile, requiring no additional preparation beyond standard aseptic handling. Storage should follow manufacturer guidelines for sterile medical devices—typically in a clean, dry environment away from direct sunlight or extreme temperatures to preserve sterility and integrity until use.

• What regulatory pathway was followed for the FDA clearance of this device, and who is the applicant?

  The Sensi-Touch Epidural Anesthesia Tray received FDA clearance through a Traditional 510(k) pathway (K950929), filed under the Anesthesiology advisory committee (AN). Sherwood Medical Co., based in St. Louis, MO, served as the applicant for this clearance, adhering to FDA regulations for Class II anesthesia conduction kits (product code: CAZ).