Cleared Traditional

K092983 - PANPAC HSG CATHETER SET

K092983 is an FDA 510(k) clearance for PANPAC HSG CATHETER SET, 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 252-day FDA review.

K092983 · Panpac Medical Corporation · Obstetrics & Gynecology device
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Jun 2010
Decision
252d
Days
Class 2
Risk

K092983 is an FDA 510(k) clearance for the PANPAC HSG CATHETER SET. 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 June 7, 2010 after a review of 252 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 - K092983

510(k) Number K092983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date June 07, 2010
Days to Decision 252 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 161d · This submission: 252d
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 K092983.
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
K102898 · Panpac Medical Corporation · Dec 2011
FEMCHEC PRESSURE MANAGEMET DEVICE
K110993 · Femasys, Inc. · Oct 2011
FEMVUE SALINE-AIR DEVICE
K110288 · Femasys, Inc. · Apr 2011
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
K092969 · Sterling Medical, Inc. · Apr 2010
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
K092983 · PANPAC HSG CATHETER SET
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