Cleared Traditional

K111425 - OLYMPUS LTF-S190-10

K111425 is the FDA 510(k) clearance for OLYMPUS LTF-S190-10 by Olympus Medical Systems Corp.. It is a Class 2 Obstetrics & Gynecology device (product code HET) cleared through the Traditional 510(k) pathway after a 333-day FDA review.

K111425 · Olympus Medical Systems Corp. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
333d
Days
Class 2
Risk

K111425 is an FDA 510(k) clearance for the OLYMPUS LTF-S190-10, OLUMPUS OTV-S190, OLYMPUS CLV-S190. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on April 20, 2012 after a review of 333 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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. Elevated predicate reliance profile. 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 Olympus Medical Systems Corp. devices

Submission Details

510(k) Number K111425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2011
Decision Date April 20, 2012
Days to Decision 333 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
173d slower than avg
Panel avg: 160d · This submission: 333d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 124
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K111425.
VISERA 4K UHD SYSTEM
K151011 · Olympus Medical Systems Corp. · Oct 2015
MORCELLEX SIGMA GENERATOR
K131656 · Ethicon, Inc. · Sep 2013
OLYMPUS LTF-190-10-3D, MAJ-Y0154, OLYMPUS CV-190
K123365 · Olympus Medical Systems Corp. · Mar 2013
ENDOEYE HD II
K111788 · Olympus America, Inc. · Jan 2012
GYNCARE MORCELLEX TISSUE MORCELLATOR
K100280 · Ethicon, Inc. · Mar 2010
ENDOSCOPIC CO2 REGULATION UNIT UCR
K081173 · Olympus Medical Systems Corporation · Dec 2008