Identifiers
- 510(k) Number
- K183505 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 KY Banksy Moisture is a personal lubricant designed for use in obstetrics and gynecology. It is classified as a Class II medical device under the FDA’s regulation number 21 CFR 884.5300, intended for intimate personal use to enhance comfort during medical procedures.
This device is supplied as a single-use product and is regulated under the FDA’s 510(k) clearance process (K183505). It is intended for sterile application in clinical settings, adhering to standard medical lubricant practices. The product code NUC categorizes it within the FDA’s administrative classification system, with no third-party involvement in its review.
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. Sources consulted: K183505 FDA 510(k) - KY Banksy Moisture | Rb Health (Us), LLC, KY Banksy Moisture — FDA 510 (k) K183505 | MedTracker, KY Banksy Moisture (K183505) — FDA 510 (k) | Innolitics, Ky Banksy Moisture 510 (k) FDA Premarket Notification K183505 RB Health ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183505 | Class II | Active |
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Manufacturer
- Manufacturer
- RB Health (us) LLC
- FDA Applicant
- Rb Health (Us), LLC
Sources (1)
- FDA 510(k) K183505 24 fields · synced Oct 6, 2026