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Model 1101M & 1151M Urolab Micro Urodynamic Record

by Life-Tech Intl., Inc.

510(k) K863168

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK863168 Date24 Oct 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
FAP
Device Class
Class II
Regulation
21 CFR Part 876.1620
Advisory Committee
Gastroenterology, Urology
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 Model 1101M & 1151M Urolab Micro Urodynamic Record is a urodynamics measurement system used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles.

This device is supplied by Life-Tech Intl., Inc. and is FDA 510(k) cleared with K number K863168, classified as a Class II device under product code FAP. It is intended for use in urology and gastroenterology settings, with a decision of Substantially Equivalent made on October 24, 1986.

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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 Urolab Micro Urodynamic Record used for?

    The Urolab Micro Urodynamic Record is a measurement system used to assess urinary bladder function by measuring volume and pressure as the bladder is filled with carbon dioxide or water through a catheter. It can also record electrical activity of the muscles involved in urination.

  • How is the Urolab Micro Urodynamic Record supplied?

    The device is supplied by Life-Tech Intl., Inc. It is FDA 510(k) cleared with K number K863168, classified as a Class II device under product code FAP, and is intended for use in urology and gastroenterology settings.

  • Is the Urolab Micro Urodynamic Record reusable or single-use?

    The device data does not specify whether the Urolab Micro Urodynamic Record is designed for single-use or multiple uses. This information would be detailed in the product's instructions for use provided by the manufacturer.

  • What are the regulatory approvals for the Urolab Micro Urodynamic Record?

    The device is FDA 510(k) cleared with K number K863168, with a decision of Substantially Equivalent made on October 24, 1986. It is classified as a Class II device under product code FAP and is intended for use in urology and gastroenterology settings.