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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-08-18 under 510(k) 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. The listed applicant is Covidien. The 510(k) number is K161105.

When did Reprocessed Compression Garments receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprocessed Compression Garments?

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

What is the FDA product code for Reprocessed Compression Garments?

The FDA product code for Reprocessed Compression Garments is JOW.

Other records listing Covidien as applicant

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.

View all 119 devices →

Related Devices (Code: JOW)

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.

Official Source

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