Cleared Traditional

K102379 - LTF-Y0009

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

K102379 is an FDA 510(k) clearance for LTF-Y0009, manufactured by Olympus Medical Systems Corporation. The device is a Class 2 General & Plastic Surgery device with 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
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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

FDA 510(k) Submission Details - K102379

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.

GCJ Device Classification - Class 2, Special Controls

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 1067
Devices cleared under the same product code (GCJ) and FDA review panel - the closest regulatory comparables to K102379.
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SILS PORT
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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