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FDA 510(k)

Carex Hybrid Personal Lubricant

K-Number: K223519 · 2023-08-11

ApplicantKarex Industries Sdn. Bhd.
Decision Date2023-08-11
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Carex Hybrid Personal Lubricant is a medical device manufactured by Karex Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2023-08-11 under approval number K223519. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carex Hybrid Personal Lubricant?

Carex Hybrid Personal Lubricant is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Karex Industries Sdn. Bhd.. The 510(k) number is K223519.

When was Carex Hybrid Personal Lubricant approved by the FDA?

Carex Hybrid Personal Lubricant received FDA 510(k) clearance on 2023-08-11, under approval number K223519.

What company makes Carex Hybrid Personal Lubricant?

Carex Hybrid Personal Lubricant is manufactured by Karex Industries Sdn. Bhd..

What is the FDA product code for Carex Hybrid Personal Lubricant?

The FDA product code for Carex Hybrid Personal Lubricant is NUC.

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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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