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FDA 510(k)

GENESIS (MS-P02-GEN)

K-Number: K240843 · 2024-10-07

Decision Date2024-10-07
Product CodeILK
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GENESIS (MS-P02-GEN) is the device name listed in this FDA 510(k) record. The listed applicant is Climbing Steps, Inc.. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K240843. The device is classified under product code ILK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESIS (MS-P02-GEN)?

GENESIS (MS-P02-GEN) is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Climbing Steps, Inc.. The 510(k) number is K240843.

When did GENESIS (MS-P02-GEN) receive FDA 510(k) clearance?

GENESIS (MS-P02-GEN) received FDA 510(k) clearance on 2024-10-07, under 510(k) number K240843.

Who is the listed applicant for GENESIS (MS-P02-GEN)?

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

What is the FDA product code for GENESIS (MS-P02-GEN)?

The FDA product code for GENESIS (MS-P02-GEN) is ILK.

Related Devices (Code: ILK)

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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