Cleared Traditional

K141330 - ENDO-CORD

K141330 is an FDA 510(k) clearance for ENDO-CORD, manufactured by Enroxtech, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K141330 · Enroxtech, Inc. · General & Plastic Surgery device
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Dec 2014
Decision
208d
Days
Class 2
Risk

K141330 is an FDA 510(k) clearance for the ENDO-CORD. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Enroxtech, Inc. (Boulder, US). The FDA issued a Cleared decision on December 15, 2014 after a review of 208 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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 Enroxtech, Inc. devices

FDA 510(k) Submission Details - K141330

510(k) Number K141330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2014
Decision Date December 15, 2014
Days to Decision 208 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 115d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FST Device Classification - Class 2, Special Controls

Product Code FST Light, Surgical, Fiberoptic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 - FST Light, Surgical, Fiberoptic

All 16
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