Cleared Special

K981859 - SURGIFLATOR-20 ECU

K981859 is an FDA 510(k) clearance for SURGIFLATOR-20 ECU, manufactured by W.O.M. World of Medicine GmbH. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Special 510(k) pathway after a 30-day FDA review.

K981859 · W.O.M. World of Medicine GmbH · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
30d
Days
Class 2
Risk

K981859 is an FDA 510(k) clearance for the SURGIFLATOR-20 ECU. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Washington, US). The FDA issued a Cleared decision on June 26, 1998 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K981859

510(k) Number K981859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1998
Decision Date June 26, 1998
Days to Decision 30 days
Submission Type Special
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
131d faster than avg
Panel avg: 161d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K981859.
CO2 GAS WARMING UNIT (6-800-00)
K972675 · Northgate Technologies, Inc. · Sep 1998
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
FILTER HEATER/HYDRATOR INSUFFLATION GAS CONDITIONER
K970866 · Georgia Biomedical, Inc. · Jan 1998
SURGIFLATOR-30
K973432 · W.O.M. World of Medicine GmbH · Dec 1997
K981859 · SURGIFLATOR-20 ECU
Download PDF FDA Summary W.O.M. World of Medic…