Cleared Traditional

K030693 - KENTEX DISPOSABLE VAGINAL SPECULUM
(FDA 510(k) Clearance)

K030693 · Kentron Health Care, Inc. · Obstetrics & Gynecology
Aug 2003
Decision
175d
Days
Class 2
Risk

K030693 is an FDA 510(k) clearance for the KENTEX DISPOSABLE VAGINAL SPECULUM. This device is classified as a Speculum, Vaginal, Nonmetal (Class II — Special Controls, product code HIB).

Submitted by Kentron Health Care, Inc. (Springfield, US). The FDA issued a Cleared decision on August 27, 2003, 175 days after receiving the submission on March 5, 2003.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K030693 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2003
Decision Date August 27, 2003
Days to Decision 175 days
Submission Type Traditional
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