Cleared Traditional

K140008 - VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVE...

K140008 is the FDA 510(k) clearance for VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVE... by Terumo Cardiovascular Systems Corporation. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K140008 · Terumo Cardiovascular Systems Corporation · General & Plastic Surgery device
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Oct 2014
Decision
302d
Days
Class 2
Risk

K140008 is an FDA 510(k) clearance for the VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on October 31, 2014 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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. Elevated predicate reliance profile. 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 Terumo Cardiovascular Systems Corporation devices

Submission Details

510(k) Number K140008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2014
Decision Date October 31, 2014
Days to Decision 302 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
187d slower than avg
Panel avg: 115d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

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