JO for Him H2O Gel Original Personal Lubricant— 510(k) K192203
Substantially EquivalentUnited Consortium
FDA 510(k) clearance K192203 for JO for Him H2O Gel Original Personal Lubricant, Substantially Equivalent on 2020-02-10. Applicant: United Consortium. Device class: 2.
Clearance details
- Applicant
- United Consortium
- Product code
- Code NUC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valencia, CA, US
Recent devices under product code NUC
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- K183584 — JO H2O Jelly Original Personal Lubricant
- K183384 — JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
Adverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.