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Intrauterine Catheter

by Ram Development

510(k) K861305

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 NumberK861305 Date11 Dec 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  • Withdrawn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
HDR
Device Class
Class II
Regulation
21 CFR Part 884.5250
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Intrauterine Catheter is a medical device used for assessing uterine contractions during labor and delivery. It is designed to provide a reliable, quantitative measure of uterine activity, overcoming limitations of external monitoring methods.

The device is supplied as a single-use item and is intended for internal monitoring of uterine contractions. It is regulated under FDA 510(k) clearance and is not reusable. Proper storage and handling are required to maintain sterility.

Other devices from Ram Development

  • Stopcock

    Class II

Questions

AI-generated answers, 26 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 Intrauterine Catheter used for?

    This device is used to assess uterine contractions during labor and delivery, providing a quantitative measure that overcomes the limitations of external monitoring methods.

  • Is the Intrauterine Catheter reusable?

    No, the device is supplied as a single-use item and is not intended for reuse. Proper storage and handling are required to maintain sterility.

  • How is the Intrauterine Catheter regulated?

    The device is regulated under FDA 510(k) clearance and has been determined to be substantially equivalent to predicate devices.