Cleared Traditional

K092980 - PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
(FDA 510(k) Clearance)

K092980 · Panpac Medical Corporation · Obstetrics & Gynecology device

Mar 2010

Decision

164d

Days

Class 2

Risk

K092980 is an FDA 510(k) clearance for the PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5. This device is classified as a Cannula, Manipulator/injector, Uterine (Class II - Special Controls, product code LKF).

Submitted by Panpac Medical Corporation (Shi-Chih City, Taipei Hsien, TW). The FDA issued a Cleared decision on March 11, 2010, 164 days after receiving the submission on September 28, 2009.

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

Submission Details

510(k) Number	K092980 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 2009
Decision Date	March 11, 2010
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement