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FDA 510(k)

Benesta Medical Sterilization Tray

K-Number: K193603 · 2020-07-20

Decision Date2020-07-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Benesta Medical Sterilization Tray is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2020-07-20 under 510(k) number K193603. 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 Benesta Medical Sterilization Tray?

Benesta Medical Sterilization Tray is a medical device that received FDA 510(k) clearance on 2020-07-20. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K193603.

When did Benesta Medical Sterilization Tray receive FDA 510(k) clearance?

Benesta Medical Sterilization Tray received FDA 510(k) clearance on 2020-07-20, under 510(k) number K193603.

Who is the listed applicant for Benesta Medical Sterilization Tray?

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

What is the FDA product code for Benesta Medical Sterilization Tray?

The FDA product code for Benesta Medical Sterilization Tray is KCT.

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 Caldera Medical, 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.

View all 8 devices →

Related Devices (Code: KCT)

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

View on FDA Database →

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