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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 44
Devices cleared under the same product code (FST) and FDA review panel - the closest regulatory comparables to K101496.
EIGR SURGICAL ILLUMINATION SYSTEM
K113697 · Invuity, Inc. · Feb 2012
CABLECAP
K113330 · Sensormed · Jan 2012
ISOLED AC-POWERED LED HEADLIGHT SYSTEM
K102266 · Isolux, LLC · Sep 2010
21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS
K100388 · Medical Illumination International, Inc. · Jun 2010
HARMONY VLED SURGICAL LIGHTNING SYSTEM
K100395 · STERIS Corporation · Mar 2010
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST
K093386 · Bfw, Inc. · Jan 2010
K101496 · CABLECAP MODEL: WLF, STZ, ACM
Download PDF FDA Summary Sensormed