Cleared Special

K061762 - TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061762 · Cardinal Health, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
40d
Days
Class 2
Risk

K061762 is an FDA 510(k) clearance for the TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Cardinal Health, Inc. (Waukegan, US). The FDA issued a Cleared decision on August 1, 2006 after a review of 40 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardinal Health, Inc. devices

Submission Details

510(k) Number K061762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2006
Decision Date August 01, 2006
Days to Decision 40 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 128d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 Hospital devices follow this clearance model.