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Unicare System, Unicare Manipulator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163214

by Clearpath Surgical, Inc.

Identifiers

510(k) Number
K163214 FDA 510(k)
FDA Product Code
LKF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.4530 FDA 510(k)
Regulation Number
884.4530 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Unicare System is a sterile, single-use surgical instrument for uterine manipulation and fluid injection during laparoscopic procedures. It comprises a rigid, curved stainless steel cannula with a bulbous tip, a sliding tube, a rear Stabilizer, and interchangeable forward Collars.

The device is intended for use in laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, and laparoscopic tubal procedures. It is classified as a Class II medical device with product code LKF and received FDA 510(k) clearance with K number K163214.

Frequently asked questions

What is the Unicare System used for in laparoscopic procedures?

The Unicare System is a sterile, single-use surgical instrument designed for uterine manipulation and fluid injection during laparoscopic procedures such as LAVH, TLH, minilap, and laparoscopic tubal procedures.

What components are included in the Unicare System?

The system comprises a rigid, curved stainless steel cannula with a bulbous tip, a sliding tube, a rear Stabilizer, and interchangeable forward Collars to accommodate different procedural needs.

Is the Unicare System reusable or single-use?

The Unicare System is designed as a sterile, single-use surgical instrument, meaning it should be discarded after a single procedure to ensure patient safety and maintain device integrity.

What regulatory status does the Unicare System have?

The Unicare System is classified as a Class II medical device with product code LKF and received FDA 510(k) clearance with K number K163214, indicating it is substantially equivalent to predicate devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Unicare System, Unicare Manipulator by ClearPath Surgical, Inc. | FDA ..., Unicare System, Unicare Manipulator (K163214) — FDA 510 (k) | Innolitics, Unicare System, Unicare Manipulator 510(k) K163214 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Clearpath Surgical, Inc.

Sources (1)

  • FDA 510(k) K163214 24 fields · synced Sep 25, 2026