Cleared Traditional

SMARTWAND-DTX (K093557) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K093557 · Clearcount Medical Solutions · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
32d
Days
Class 1
Risk

K093557 is an FDA 510(k) clearance for the SMARTWAND-DTX. Classified as Counter, Sponge, Surgical (product code LWH), Class I - General Controls.

Submitted by Clearcount Medical Solutions (Pittsburgh, US). The FDA issued a Cleared decision on December 18, 2009 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.2740 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K093557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2009
Decision Date December 18, 2009
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code LWH Counter, Sponge, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.