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Ultra Catheter Set

by Lyco Enterprises, Inc.

510(k) K001115

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001115 Date17 May 2000ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ultra Catheter Set is a uterine cannula, manipulator, and injector. It is designed for use within the field of obstetrics and gynecology.

This device is a Class 2 medical device regulated under 21 CFR 884.4530. It received FDA 510(k) clearance on May 17, 2000, under the submission number K001115.

Other devices from Lyco Enterprises, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Ultra Catheter Set?

    The Ultra Catheter Set is designed to serve as a uterine cannula, manipulator, and injector for clinical use within the field of obstetrics and gynecology.

  • What is the regulatory status of this device?

    The Ultra Catheter Set is a Class 2 medical device regulated under 21 CFR 884.4530. It received FDA 510(k) clearance on May 17, 2000, under submission number K001115.

  • Which medical specialty is this device intended for?

    This device is intended for use in the field of obstetrics and gynecology, as indicated by its classification under the OB advisory committee.