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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Suretex Limited. It received FDA 510(k) clearance on 2022-09-30 under 510(k) 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. The listed applicant is Suretex Limited. The 510(k) number is K221243.

When did OFNat Lubricant (L15) receive FDA 510(k) clearance?

OFNat Lubricant (L15) received FDA 510(k) clearance on 2022-09-30, under 510(k) number K221243.

Who is the listed applicant for OFNat Lubricant (L15)?

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

What is the FDA product code for OFNat Lubricant (L15)?

The FDA product code for OFNat Lubricant (L15) is NUC.

Other records listing Suretex Limited 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.

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Related Devices (Code: NUC)

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.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

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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