OFNat Lubricant (L15)
K-Number: K221243 · 2022-09-30
ApplicantSuretex Limited
Decision Date2022-09-30
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
OFNat Lubricant (L15) is a medical device manufactured by Suretex Limited. It received FDA 510(k) clearance on 2022-09-30 under approval number K221243. 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 OFNat Lubricant (L15)?
OFNat Lubricant (L15) is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Suretex Limited. The 510(k) number is K221243.
When was OFNat Lubricant (L15) approved by the FDA?
OFNat Lubricant (L15) received FDA 510(k) clearance on 2022-09-30, under approval number K221243.
What company makes OFNat Lubricant (L15)?
OFNat Lubricant (L15) is manufactured by Suretex Limited.
What is the FDA product code for OFNat Lubricant (L15)?
The FDA product code for OFNat Lubricant (L15) 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.