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FDA 510(k)

Reprocessed Compression Garments

K-Number: K161105 · 2016-08-18

ApplicantCovidien
Decision Date2016-08-18
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Compression Garments is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-08-18 under approval number K161105. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Compression Garments?

Reprocessed Compression Garments is a medical device that received FDA 510(k) clearance on 2016-08-18. It is manufactured by Covidien. The 510(k) number is K161105.

When was Reprocessed Compression Garments approved by the FDA?

Reprocessed Compression Garments received FDA 510(k) clearance on 2016-08-18, under approval number K161105.

What company makes Reprocessed Compression Garments?

Reprocessed Compression Garments is manufactured by Covidien.

What is the FDA product code for Reprocessed Compression Garments?

The FDA product code for Reprocessed Compression Garments is JOW.

Related Clinical Trials

NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07220226 Venous Compression in Fontan NOT_YET_RECRUITING

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Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products K150980Venous Assist SystemDaesung Maref Co., 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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