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Needle Guide (For Ultrasound Transducers) K862364

by Swemed Laboratories, Inc.

510(k) K862364

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)SN Traditional NumberK862364 Date19 Aug 1986DecidedStatusActive

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  • Withdrawn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)

Full name
Needle Guide (for Ultrasound Transducers)
510(k) Number
FDA Product Code
HEM
Device Class
Class II
Regulation
21 CFR Part 884.2225
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SN

Overview

AI-generated summary, 25 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 Needle Guide (For Ultrasound Transducers) is a medical device designed to assist in the precise placement of needles during ultrasound-guided procedures. It is intended for use in obstetrics and gynecology applications, as indicated by its classification as an Ultrasonic Obstetric-Gynecologic Imager.

The device is supplied as a single-use item and is intended for use with ultrasound transducers. It is not specified as sterile, and no storage conditions are provided. The device has received FDA 510(k) clearance under K862364, with a decision date of August 19, 1986.

Other devices from Swemed Laboratories, Inc.

Questions

AI-generated answers, 25 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 this device used for?

    It is designed to assist with the precise placement of needles during ultrasound-guided procedures, specifically indicated for obstetrics and gynecology applications.

  • Is the device sterile?

    No, the device is not specified as sterile in the provided data.

  • Is it intended for single or multiple uses?

    The device is supplied as a single-use item.

  • How was the device cleared for market?

    It received FDA 510(k) clearance under K862364, with a decision date of August 19, 1986.