Cleared Traditional

K093557 - SMARTWAND-DTX

K093557 is an FDA 510(k) clearance for SMARTWAND-DTX, manufactured by Clearcount Medical Solutions. The device is a Class 1 General & Plastic Surgery device with product code LWH cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K093557 · Clearcount Medical Solutions · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K093557

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
Combination Product No
PCCP Authorized No
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.

LWH Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LWH Counter, Sponge, Surgical

All 14
Devices cleared under the same product code (LWH) and FDA review panel - the closest regulatory comparables to K093557.
PIXEL APP
K121274 · Gauss Surgical, Inc., · Jun 2012
PIXEL APP
K120473 · Gauss Surgical, Inc., · Apr 2012
ORLOCATE SYSTEM MODEL ORL 100
K100551 · Haldor Advanced Technologies, Ltd. · Aug 2010
SMARTSPONGE PLUS SYSTEM
K073180 · Clearcount Medical Solutions, Inc. · Nov 2007
SMARTSPONGE SYSTEM
K071355 · Clearcount Medical Solutions, Inc. · May 2007
MEDLINE SURGICAL SPONGE SCANNER
K061316 · Medline Industries, Inc. · Nov 2006

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K093557 · SMARTWAND-DTX
Download PDF FDA Summary Clearcount Medical So…