Specialty Set Model IV7A01

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

510(k) Number

K830891 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from Valleylab, Inc. →

• What is the Specialty Set Model IV7A01 used for?

  The Specialty Set Model IV7A01 is a medical device classified under product code FPA, intended for general hospital use. It is designed for specific medical applications and is substantially equivalent to predicate devices.

• How is the Specialty Set Model IV7A01 supplied?

  The Specialty Set Model IV7A01 is supplied by Valleylab, Inc. and is available in various sizes and configurations as specified by the manufacturer. Storage and handling requirements should follow the directions provided by Valleylab, Inc.

• What is the regulatory status of the Specialty Set Model IV7A01?

  The Specialty Set Model IV7A01 received FDA 510(k) clearance on April 14, 1983, with the clearance number K830891. It is classified as substantially equivalent under product code FPA and was reviewed by the HO advisory committee.

• Is the Specialty Set Model IV7A01 a single-use device?

  The device data does not specify whether the Specialty Set Model IV7A01 is designed for single-use or reuse. This information should be obtained directly from Valleylab, Inc. or the product documentation.