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FDA 510(k)

Medline General Surgery Tray

K-Number: K213481 · 2022-05-24

Decision Date2022-05-24
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medline General Surgery Tray 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 2022-05-24 under 510(k) number K213481. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline General Surgery Tray?

Medline General Surgery Tray is a medical device that received FDA 510(k) clearance on 2022-05-24. The listed applicant is Medline Industries, Inc.. The 510(k) number is K213481.

When did Medline General Surgery Tray receive FDA 510(k) clearance?

Medline General Surgery Tray received FDA 510(k) clearance on 2022-05-24, under 510(k) number K213481.

Who is the listed applicant for Medline General Surgery Tray?

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 General Surgery Tray?

The FDA product code for Medline General Surgery Tray is LRO.

Related Clinical Trials

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.

Other records listing Medline Industries, Inc. 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.

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Related Devices (Code: LRO)

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.