Unimat Plus

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

Full name

Ksea Unimat Plus

510(k) Number

K963949 ↗

FDA Product Code

HET

Device Class

Class II

Regulation

21 CFR Part 884.1720

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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• What is the primary use case for the KSEA Unimat Plus in clinical settings?

  The KSEA Unimat Plus is specifically designed for gynecologic and obstetric procedures, providing controlled irrigation and aspiration of the surgical site. It delivers a fixed flow rate of 3.5 liters per minute with a maximum irrigation pressure of 400 mm Hg, making it suitable for maintaining clear visibility and fluid balance during these specialized surgeries.

• Is the KSEA Unimat Plus intended for single-use or reusable applications?

  The KSEA Unimat Plus is supplied as a reusable medical instrument, meaning it is intended for repeated use after proper cleaning, sterilization, and maintenance in accordance with manufacturer guidelines. This design aligns with its classification as a Class II device under FDA regulations.

• How does the KSEA Unimat Plus differ from other irrigation/aspiration systems in terms of regulatory approval?

  The KSEA Unimat Plus received FDA 510(k) clearance through the Traditional pathway in 1996, demonstrating its equivalence to a predicate device. It is classified under product code EOB and is intended for use in surgical settings as part of a system with compatible accessories for obstetrics/gynecology procedures, as indicated by its advisory committee designation.

• What are the key specifications that define the performance of the KSEA Unimat Plus?

  The device operates with a fixed flow rate of 3.5 liters per minute and a maximum irrigation pressure of 400 mm Hg, ensuring precise fluid control during gynecologic and obstetric surgeries. These specifications are critical for maintaining surgical site conditions while minimizing risks like over-pressurization or inadequate irrigation.