Cleared Traditional

K053494 - OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE (FDA 510(k) Clearance)

K053494 · Fertipro NV · Obstetrics & Gynecology device

Mar 2006

Decision

98d

Days

Class 2

Risk

K053494 is an FDA 510(k) clearance for the OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE. This device is classified as a Media, Reproductive (Class II - Special Controls, product code MQL).

Submitted by Fertipro NV (Irvine, US). The FDA issued a Cleared decision on March 23, 2006, 98 days after receiving the submission on December 15, 2005.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number	K053494 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 15, 2005
Decision Date	March 23, 2006
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF