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Global Healthcare Vaginal Speculum

by Dynascend Consulting Int'L, LLC

510(k) K013835

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 NumberK013835 Date17 Jan 2002ClearedStatusActive

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  • Withdrawn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
HIB
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Global Healthcare Vaginal Speculum is a nonmetal vaginal speculum, classified under FDA regulation 884.4530. It is designed to facilitate general vaginal examinations by providing visual access to the cervix through gentle insertion into the vagina.

This device is intended for single-use in obstetrics and gynecology settings. It is supplied sterile and falls under FDA 510(k) clearance (K013835) with a classification as substantially equivalent (SESE). No MRI safety or reusable specifications are noted in the regulatory data.

Questions

AI-generated answers, 19 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 medical specialties is this vaginal speculum designed for and how is it intended to be used?

    The Global Healthcare Vaginal Speculum is specifically designed for use in obstetrics and gynecology settings. It is intended for single-use during general vaginal examinations to provide clear visual access to the cervix through gentle insertion into the vagina.

  • Is this device reusable or single-use, and how is it supplied?

    This device is explicitly intended for single-use only. It is supplied sterile, ensuring readiness for immediate clinical use without the need for reprocessing or sterilization between patients.

  • What sizes or models of this vaginal speculum are available?

    The device data lists multiple registration numbers, indicating multiple models or sizes are available (e.g., 3034669683, 3030447506, etc.). While exact dimensions or variations are not specified, the presence of these unique identifiers suggests a range of options to accommodate different patient needs.

  • How should this device be stored to maintain its sterility and functionality?

    Since the device is supplied sterile and intended for single-use, it should be stored in its original, sealed packaging until use. Proper storage conditions—such as a clean, dry environment away from direct sunlight or extreme temperatures—should be maintained to preserve sterility and integrity until deployment.

  • What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians?

    The Global Healthcare Vaginal Speculum received FDA clearance through a 510(k) submission, classified as substantially equivalent (SESE) to a predicate device under regulation 884.4530. This means it has been evaluated by the FDA’s Obstetrics/Gynecology (OB) advisory committee and deemed comparable in safety and effectiveness to existing devices, ensuring it meets established standards for vaginal specula in clinical practice.