Cleared Traditional

K973432 - SURGIFLATOR-30

K973432 is the FDA 510(k) clearance for SURGIFLATOR-30 by W.O.M. World of Medicine GmbH. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K973432 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1997
Decision
90d
Days
Class 2
Risk

K973432 is an FDA 510(k) clearance for the SURGIFLATOR-30. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on December 9, 1997 after a review of 90 days - within the typical 510(k) review window.

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 GmbH devices

Submission Details

510(k) Number K973432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1997
Decision Date December 09, 1997
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K973432.
OMNIFLATOR 6630(6-630-00)
K973447 · Northgate Technologies, Inc. · Sep 1998
LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)
K981334 · Richard Wolf Medical Instruments Corp. · Sep 1998
KSEA N2O ENDOFLATOR
K980134 · KARL STORZ Endoscopy-America, Inc. · Apr 1998
KSEA CO2 ENDOFLATOR
K963423 · Karl Storz Endoscopy · May 1997
SNOWDEN-PENCER COMPUTERIZED HIGH FLOW INSUFFLATOR
K962683 · Deknatel, Inc. · Jan 1997
KSEA THERMOFLATOR (MODEL 26 4320 20)
K955073 · KARL STORZ Endoscopy-America, Inc. · Dec 1996