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FDA 510(k)

SACS PRO

K-Number: K243177 · 2024-12-23

Decision Date2024-12-23
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SACS PRO is the device name listed in this FDA 510(k) record. The listed applicant is Elastimed , Ltd.. It received FDA 510(k) clearance on 2024-12-23 under 510(k) number K243177. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SACS PRO?

SACS PRO is a medical device that received FDA 510(k) clearance on 2024-12-23. The listed applicant is Elastimed , Ltd.. The 510(k) number is K243177.

When did SACS PRO receive FDA 510(k) clearance?

SACS PRO received FDA 510(k) clearance on 2024-12-23, under 510(k) number K243177.

Who is the listed applicant for SACS PRO?

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

What is the FDA product code for SACS PRO?

The FDA product code for SACS PRO is IRP.

Other records listing Elastimed , Ltd. 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.

Related Devices (Code: IRP)

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.