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FDA 510(k)

ACCUMESH DEPLOYMENT SYSTEM

K-Number: K123066 · 2012-10-16

ApplicantCovidien, LLC
Decision Date2012-10-16
Product CodeORQ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCUMESH DEPLOYMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2012-10-16 under 510(k) number K123066. The device is classified under product code ORQ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUMESH DEPLOYMENT SYSTEM?

ACCUMESH DEPLOYMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2012-10-16. The listed applicant is Covidien, LLC. The 510(k) number is K123066.

When did ACCUMESH DEPLOYMENT SYSTEM receive FDA 510(k) clearance?

ACCUMESH DEPLOYMENT SYSTEM received FDA 510(k) clearance on 2012-10-16, under 510(k) number K123066.

Who is the listed applicant for ACCUMESH DEPLOYMENT SYSTEM?

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

What is the FDA product code for ACCUMESH DEPLOYMENT SYSTEM?

The FDA product code for ACCUMESH DEPLOYMENT SYSTEM is ORQ.

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Related Devices (Code: ORQ)

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.

K250395BioBrace ® RC Delivery SystemConmed CorporationK130782ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK121139ACCUMESH DEPLOYMENT SYSTEMCovidien, LLCK103269PATCHASSIST LARGEPolytouch Medical, Ltd.K101218PATCHASSISTPolytouch Medical, Ltd.

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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