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FDA 510(k)

MEDLINE SURGICAL SPONGE SCANNER

K-Number: K061316 · 2006-11-02

ApplicantMedline Industries, Inc.
Decision Date2006-11-02
Product CodeLWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDLINE SURGICAL SPONGE SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2006-11-02 under 510(k) number K061316. 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 MEDLINE SURGICAL SPONGE SCANNER?

MEDLINE SURGICAL SPONGE SCANNER is a medical device that received FDA 510(k) clearance on 2006-11-02. The listed applicant is Medline Industries, Inc.. The 510(k) number is K061316.

When did MEDLINE SURGICAL SPONGE SCANNER receive FDA 510(k) clearance?

MEDLINE SURGICAL SPONGE SCANNER received FDA 510(k) clearance on 2006-11-02, under 510(k) number K061316.

Who is the listed applicant for MEDLINE SURGICAL SPONGE SCANNER?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDLINE SURGICAL SPONGE SCANNER?

The FDA product code for MEDLINE SURGICAL SPONGE SCANNER 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.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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