Cleared Traditional

K082813 - STRYKER LED LIGHTSOURCE

K082813 is an FDA 510(k) clearance for STRYKER LED LIGHTSOURCE, manufactured by Stryker Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FCW cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K082813 · Stryker Corp. · Gastroenterology & Urology device
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Dec 2008
Decision
86d
Days
Class 2
Risk

K082813 is an FDA 510(k) clearance for the STRYKER LED LIGHTSOURCE. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Corp. devices

FDA 510(k) Submission Details - K082813

510(k) Number K082813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2008
Decision Date December 19, 2008
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 131d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCW Device Classification - Class 2, Special Controls

Product Code FCW Light Source, Fiberoptic, Routine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCW Light Source, Fiberoptic, Routine

All 20
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