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FDA 510(k)

Steripack cases and Tray Systems

K-Number: K193066 · 2020-08-06

ApplicantAvalign Technologies, Inc.
Decision Date2020-08-06
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Steripack cases and Tray Systems is a medical device manufactured by Avalign Technologies, Inc.. It received FDA 510(k) clearance on 2020-08-06 under approval number K193066. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Steripack cases and Tray Systems?

Steripack cases and Tray Systems is a medical device that received FDA 510(k) clearance on 2020-08-06. It is manufactured by Avalign Technologies, Inc.. The 510(k) number is K193066.

When was Steripack cases and Tray Systems approved by the FDA?

Steripack cases and Tray Systems received FDA 510(k) clearance on 2020-08-06, under approval number K193066.

What company makes Steripack cases and Tray Systems?

Steripack cases and Tray Systems is manufactured by Avalign Technologies, Inc..

What is the FDA product code for Steripack cases and Tray Systems?

The FDA product code for Steripack cases and Tray Systems is KCT.

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Related PubMed Literature

PMID: 42207283 [Legal responsibility in AI-assisted radiological reporting]. Radiologie (Heidelberg, Germany) (2026)

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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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