MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303— 510(k) K984211

Name: FDA 510(k) clearance K984211
Creator: U.S. Food and Drug Administration
Published: 1998-12-23

Substantially Equivalent

Medscand AB

FDA 510(k) clearance K984211 for MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303, Substantially Equivalent on 1998-12-23. Applicant: Medscand AB. Device class: 2.

Clearance details

Applicant: Medscand AB
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1998-11-24
Decision date: 1998-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malmo, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HIB

view all

K252208 — JFord Speculum Sleeve2026-03-06
K133857 — BRELLA-SPEC(TM) VAGINAL SPECULUM2014-04-28
K132668 — IOB DISPOSABLE SPECULUM2014-01-17
K130046 — CLEARSPEC SINGLE USE VAGINAL SPECULUM2013-08-06
K120743 — SPECULUM, VAGINAL, NONMETAL2012-03-23

More clearances from Medscand AB

view all

K911432 — ACCELLON CERVICAL BIOSAMPLER1993-09-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.