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FDA 510(k)

SURGICOUNT SAFETY-SPONGE SYSTEM

K-Number: K060076 · 2006-03-14

ApplicantSurgicount Medical
Decision Date2006-03-14
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGICOUNT SAFETY-SPONGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgicount Medical. It received FDA 510(k) clearance on 2006-03-14 under 510(k) number K060076. 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 SURGICOUNT SAFETY-SPONGE SYSTEM?

SURGICOUNT SAFETY-SPONGE SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-14. The listed applicant is Surgicount Medical. The 510(k) number is K060076.

When did SURGICOUNT SAFETY-SPONGE SYSTEM receive FDA 510(k) clearance?

SURGICOUNT SAFETY-SPONGE SYSTEM received FDA 510(k) clearance on 2006-03-14, under 510(k) number K060076.

Who is the listed applicant for SURGICOUNT SAFETY-SPONGE SYSTEM?

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

What is the FDA product code for SURGICOUNT SAFETY-SPONGE SYSTEM?

The FDA product code for SURGICOUNT SAFETY-SPONGE SYSTEM is LWH.

Related Clinical Trials

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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.K093557SMARTWAND-DTXClearcount Medical SolutionsK073180SMARTSPONGE PLUS SYSTEMClearcount Medical Solutions, Inc.K071355SMARTSPONGE SYSTEMClearcount Medical Solutions, 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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