SH-1

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K770344 ↗

FDA Product Code

CBN

Device Class

Class II

Regulation

21 CFR Part 868.5430

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Delta Medical Industries →

• What is the SH-1 gas-scavenging apparatus used for?

  The SH-1 is designed to capture and remove waste anesthetic gases from breathing systems in anesthesiology, ensuring safety for both patients and healthcare providers in clinical settings where anesthetic gases are administered.

• How is the SH-1 supplied and what sizes are available?

  The SH-1 is supplied in various sizes and models as specified by Delta Medical Industries. The specific size options should be selected based on clinical requirements and manufacturer recommendations.

• What is the regulatory status of the SH-1?

  The SH-1 is a Class II medical device with FDA 510(k) clearance, specifically cleared under the traditional pathway with decision code SESE, indicating it is substantially equivalent to predicate devices.

• How should the SH-1 be stored when not in use?

  The SH-1 should be stored according to the manufacturer's instructions to maintain its integrity and functionality. Proper storage conditions help ensure the device remains ready for safe and effective use when needed.