Cleared Traditional

K060723 - 40 L HIGH FLOW INSUFFLATOR F113

K060723 is an FDA 510(k) clearance for 40 L HIGH FLOW INSUFFLATOR F113, 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 69-day FDA review.

K060723 · W.O.M. World of Medicine AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
69d
Days
Class 2
Risk

K060723 is an FDA 510(k) clearance for the 40 L HIGH FLOW INSUFFLATOR F113. 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 25, 2006 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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

FDA 510(k) Submission Details - K060723

510(k) Number K060723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2006
Decision Date May 25, 2006
Days to Decision 69 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 160d · This submission: 69d
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 83
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K060723.
HIGH FLOW INSUFFLATION UNIT UHI-4
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FLO-ASSISTANT
K041560 · Northgate Technologies, Inc. · Sep 2004
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K033614 · Northgate Technologies, Inc. · Jul 2004
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · Northgate Technologies, Inc. · Jan 2003