Uberlube Personal Lubricant
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151647 FDA 510(k)
- FDA Product Code
- NUC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5300 FDA 510(k)
- Regulation Number
- 884.5300 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Uberlube Personal Lubricant is a water-based, vaginal lubricant designed to reduce friction during intimate activities. Classified as a personal lubricant, it is intended for use in obstetrics and gynecology settings to enhance comfort and facilitate medical procedures or personal use.
Supplied as single-use applicators, the lubricant is non-sterile and intended for external use only. It is classified under FDA device class II and has received 510(k) clearance, with regulatory compliance under the Medical Device Regulation (MDR). The product is available in multiple registration numbers and is intended for use in obstetrics/gynecology procedures, though not for internal medical insertion.
Frequently asked questions
What is the primary purpose of the Uberlube Personal Lubricant in clinical settings like obstetrics and gynecology?
The Uberlube Personal Lubricant is designed to reduce friction during intimate activities, enhancing comfort for patients. In clinical settings, it is intended for use in obstetrics and gynecology to facilitate medical procedures—though it is explicitly not meant for internal insertion. Its water-based formula is suitable for external use only.
Is the Uberlube lubricant sterile, and how is it supplied for clinical use?
The Uberlube lubricant is non-sterile and is supplied in single-use applicators. This means each applicator is intended for one-time use only, ensuring hygiene and preventing cross-contamination in clinical or personal settings.
Can this lubricant be reused, or is it meant for single-use only?
The Uberlube lubricant is explicitly designed for single-use only via its applicator packaging. Reuse is not recommended or supported by the manufacturer, as it could compromise hygiene and product integrity.
What regulatory pathways has Uberlube followed for this product, and how does it classify under FDA guidelines?
The Uberlube Personal Lubricant has undergone FDA 510(k) clearance and is classified under FDA device class II. It was reviewed by the Obstetrics (OB) Advisory Committee and is compliant with the Medical Device Regulation (MDR). The product falls under the NUC (Non-Uterine Contraceptive) product code, though its intended use is not for contraception.
Are there multiple sizes or models of the Uberlube lubricant, or is it available in a single formulation?
The Uberlube lubricant is available in multiple registration numbers, indicating variations in packaging or batch identifiers, but the product itself remains a single water-based formulation with no differing sizes or clinical strengths. The variations relate to regulatory compliance and distribution rather than product specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K151647 | Class II | Active |
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Manufacturer
- Manufacturer
- Uberlube, LLC
Sources (2)
- FDA 510(k) K151647 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026