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Medscand Disposable Plastic Vaginal Speculum; Easy-Spec Plastic Vaginal Speculum, Model 303

by Medscand AB

510(k) K984211

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

Overview

This Medscand disposable plastic vaginal speculum, model 303, offers a safe and efficient way to collect and store cervical mucus during fertility testing. The speculum is designed for use in obstetrics and gynecology procedures and meets the strict regulatory standards set by the European Medicines Agency (EMA).

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984211 Date23 Dec 1998ClearedStatusActive

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  • Withdrawn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

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