SPECULUM, VAGINAL, NONMETAL— 510(k) K120743

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K120743 for SPECULUM, VAGINAL, NONMETAL, Substantially Equivalent on 2012-03-23. Applicant: Welch Allyn, Inc.. Device class: 2.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2012-03-12
Decision date: 2012-03-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K120743

K-number listed on FDA's recall record

Z-0169-2016 — Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLYClass II·Terminated·Welch Allyn Inc·20151002

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120743.

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