Cleared Traditional

K101496 - CABLECAP MODEL: WLF, STZ, ACM

K101496 is an FDA 510(k) clearance for CABLECAP MODEL: WLF, manufactured by Sensormed. The device is a Class 2 General & Plastic Surgery device with product code FST cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K101496 · Sensormed · General & Plastic Surgery device
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Sep 2010
Decision
105d
Days
Class 2
Risk

K101496 is an FDA 510(k) clearance for the CABLECAP MODEL: WLF, STZ, ACM. Classified as Light, Surgical, Fiberoptic (product code FST), Class II - Special Controls.

Submitted by Sensormed (Knoxville, US). The FDA issued a Cleared decision on September 14, 2010 after a review of 105 days - within the typical 510(k) review window.

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 Sensormed devices

FDA 510(k) Submission Details - K101496

510(k) Number K101496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2010
Decision Date September 14, 2010
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 19
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