Cleared Traditional

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

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Panpac Medical Corporation (Shi-Chih City, Taipei Hsien, TW). The FDA issued a Cleared decision on March 11, 2010 after a review of 164 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 158d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.