Cleared Traditional

K063367 - 45L CORE INSUFFLATOR, MODEL F114

K063367 is an FDA 510(k) clearance for 45L CORE INSUFFLATOR, manufactured by W.O.M. World of Medicine AG. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K063367 · W.O.M. World of Medicine AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
197d
Days
Class 2
Risk

K063367 is an FDA 510(k) clearance for the 45L CORE INSUFFLATOR, MODEL F114. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by W.O.M. World of Medicine AG (Cambridge, US). The FDA issued a Cleared decision on May 23, 2007 after a review of 197 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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.

View all W.O.M. World of Medicine AG devices

FDA 510(k) Submission Details - K063367

510(k) Number K063367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2006
Decision Date May 23, 2007
Days to Decision 197 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 160d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 - HIF Insufflator, Laparoscopic

All 137
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K063367.
MODIFICATION TO: ARAGON SURGICAL LAPCAP
K073452 · Aragon Surgical, Inc. · Jan 2008
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K070783 · Sopro · Dec 2007
ARAGON SURGICAL LAPCAP
K070651 · Aragon Surgical, Inc. · May 2007
INSUFLOW DEVICE, MODEL 6198
K063546 · Lexion Medical, LLC · Jan 2007
VERESURE BELL
K061387 · Veresure, Inc. · Jul 2006
40 L HIGH FLOW INSUFFLATOR F113
K060723 · W.O.M. World of Medicine AG · May 2006