Cleared Traditional

K060414 - KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE

K060414 is an FDA 510(k) clearance for KOLSTER METHODS, manufactured by Kmi Kolster Methods, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K060414 · Kmi Kolster Methods, Inc. · General & Plastic Surgery device
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Oct 2006
Decision
249d
Days
Class 2
Risk

K060414 is an FDA 510(k) clearance for the KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Kmi Kolster Methods, Inc. (Corona, US). The FDA issued a Cleared decision on October 23, 2006 after a review of 249 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - 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.

FDA 510(k) Submission Details - K060414

510(k) Number K060414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2006
Decision Date October 23, 2006
Days to Decision 249 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 115d · This submission: 249d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 84
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K060414 · KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
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