Cleared Special

SPECULUM, VAGINAL, NONMETAL

K120743 · Welch Allyn, Inc. · Obstetrics & Gynecology
Mar 2012
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K120743 is an FDA 510(k) clearance for the SPECULUM, VAGINAL, NONMETAL, a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on March 23, 2012, 11 days after receiving the submission on March 12, 2012. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K120743 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2012
Decision Date March 23, 2012
Days to Decision 11 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIB — Speculum, Vaginal, Nonmetal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530