Cleared Traditional

K102379 - LTF-Y0009

Also marketed or referenced as:
MAJ-YOO41 XOEV-3D1

K102379 is the FDA 510(k) clearance for LTF-Y0009 by Olympus Medical Systems Corporation. It is a Class 2 General & Plastic Surgery device (product code GCJ) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K102379 · Olympus Medical Systems Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
135d
Days
Class 2
Risk

K102379 is an FDA 510(k) clearance for the LTF-Y0009. Classified as Laparoscope, General & Plastic Surgery (product code GCJ), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on January 5, 2011 after a review of 135 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K102379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2010
Decision Date January 05, 2011
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCJ Laparoscope, General & Plastic Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GCJ Laparoscope, General & Plastic Surgery

All 691
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K102379.
WECK VISTA OPTICAL BLADELESS LAPAROSCOPIC ACCESS PORT
K121380 · Teleflexmedical, Inc. · May 2012
ADAPT(TM) UNIVERSAL BALLOON OPEN ACCESS PORT
K112456 · Teleflexmedical, Inc. · Oct 2011
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100
K101077 · Intuitive Surgical, Inc. · Feb 2011
HYBRID TROCAR SYSTEM
K101937 · Aesculap, Inc. · Aug 2010
SINGLE SITE FLEXIBLE BLADELESS OBTURATOR
K101671 · Teleflexmedical, Inc. · Jun 2010
VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
K092789 · Terumo Cardiovascular Systems Corp. · May 2010