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FDA 510(k)

SMARTWAND-DTX

K-Number: K093557 · 2009-12-18

ApplicantClearcount Medical Solutions
Decision Date2009-12-18
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SMARTWAND-DTX is the device name listed in this FDA 510(k) record. The listed applicant is Clearcount Medical Solutions. It received FDA 510(k) clearance on 2009-12-18 under 510(k) number K093557. The device is classified under product code LWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTWAND-DTX?

SMARTWAND-DTX is a medical device that received FDA 510(k) clearance on 2009-12-18. The listed applicant is Clearcount Medical Solutions. The 510(k) number is K093557.

When did SMARTWAND-DTX receive FDA 510(k) clearance?

SMARTWAND-DTX received FDA 510(k) clearance on 2009-12-18, under 510(k) number K093557.

Who is the listed applicant for SMARTWAND-DTX?

The FDA 510(k) record lists Clearcount Medical Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTWAND-DTX?

The FDA product code for SMARTWAND-DTX is LWH.

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Related Devices (Code: LWH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121274PIXEL APPGauss Surgical, Inc.,K120473PIXEL APPGauss Surgical, Inc.,K100551ORLOCATE SYSTEM MODEL ORL 100Haldor Advanced Technologies, Ltd.K073180SMARTSPONGE PLUS SYSTEMClearcount Medical Solutions, Inc.K071355SMARTSPONGE SYSTEMClearcount Medical Solutions, Inc.K062642RF SURGICAL SYSTEMS INC. DETECTION SYSTEM, MODEL 100ARf Surgical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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