Cleared Traditional

K092980 - PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5

K092980 is an FDA 510(k) clearance for PANPAC UTERINE MANIPULATOR INJECTOR, manufactured by Panpac Medical Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K092980 · Panpac Medical Corporation · Obstetrics & Gynecology device
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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.

FDA 510(k) Submission Details - K092980

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 161d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - LKF Cannula, Manipulator/injector, Uterine

All 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K092980.
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0
K092984 · Panpac Medical Corporation · Apr 2010
FEMVUE CORNUAL BALLOON CATHETER
K100662 · Femasys, Inc. · Apr 2010
VCARE DX
K093556 · Conmed Corporation · Mar 2010
EZ HSG CATHETER.FOAMSEAL CATHETER
K083594 · Obg Products · Jul 2009
FEMVUE(TM) CATHETER SYSTEM
K083690 · Femasys, Inc. · Jun 2009
PROBE HOLDER SYSTEM
K071405 · Intuitive Surgical, Inc. · Oct 2007
K092980 · PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5
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