Cleared Traditional

K980134 - KSEA N2O ENDOFLATOR

K980134 is an FDA 510(k) clearance for KSEA N2O ENDOFLATOR, manufactured by KARL STORZ Endoscopy-America, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980134 · KARL STORZ Endoscopy-America, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
90d
Days
Class 2
Risk

K980134 is an FDA 510(k) clearance for the KSEA N2O ENDOFLATOR. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on April 15, 1998 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 KARL STORZ Endoscopy-America, Inc. devices

FDA 510(k) Submission Details - K980134

510(k) Number K980134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1998
Decision Date April 15, 1998
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 127
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K980134.
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
SURGIFLATOR-20 ECU
K981859 · W.O.M. World of Medicine GmbH · Jun 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
HI-TEC CO2 INSUFFLATOR TYPE 1300
K955477 · Hi Tec Medical Vertriebs-GmbH Fur Innovative Mediz · Aug 1997