POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM— 510(k) K040817

Name: FDA 510(k) clearance K040817
Creator: U.S. Food and Drug Administration
Published: 2004-06-22

Substantially Equivalent

Advanced Urological Developments

FDA 510(k) clearance K040817 for POPSPEK DISPOSABLE ADJUSTABLE VAGINAL SPECULUM, Substantially Equivalent on 2004-06-22. Applicant: Advanced Urological Developments. Device class: 2.

Clearance details

Applicant: Advanced Urological Developments
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2004-03-30
Decision date: 2004-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

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

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