Cleared Traditional

K052192 - FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I
(FDA 510(k) Clearance)

K052192 · Femspec LLC · Obstetrics & Gynecology device

Feb 2006

Decision

175d

Days

Class 2

Risk

K052192 is an FDA 510(k) clearance for the FEMSPCE-S DISPOSABLE STERILE VAGINAL SPECULUM, MODEL ST-I. This device is classified as a Speculum, Vaginal, Nonmetal (Class II - Special Controls, product code HIB).

Submitted by Femspec LLC (Port Townsend, US). The FDA issued a Cleared decision on February 2, 2006, 175 days after receiving the submission on August 11, 2005.

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

Submission Details

510(k) Number	K052192 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 2005
Decision Date	February 02, 2006
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement