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FDA 510(k)

REMEX Xcam6

K-Number: K250597 · 2025-07-31

ApplicantRemedi, Inc.
Decision Date2025-07-31
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

REMEX Xcam6 is a medical device manufactured by Remedi, Inc.. It received FDA 510(k) clearance on 2025-07-31 under approval number K250597. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEX Xcam6?

REMEX Xcam6 is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Remedi, Inc.. The 510(k) number is K250597.

When was REMEX Xcam6 approved by the FDA?

REMEX Xcam6 received FDA 510(k) clearance on 2025-07-31, under approval number K250597.

What company makes REMEX Xcam6?

REMEX Xcam6 is manufactured by Remedi, Inc..

What is the FDA product code for REMEX Xcam6?

The FDA product code for REMEX Xcam6 is IZL.

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Official Source

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