Identifiers
- 510(k) Number
- K183302 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)
KY Banksy Aloe is a personal lubricant device classified as Class II under regulation number 884.5300, with product code NUC. It is designated for use in the Obstetrics/Gynecology medical specialty.
The device received FDA 510(k) clearance (K183302) through the Traditional pathway on April 16, 2019, following a 140-day review. It is manufactured by RB Health (us) LLC and is identified as substantially equivalent to a predicate device.
Frequently asked questions
What is KY Banksy Aloe used for?
KY Banksy Aloe is designated for use in the Obstetrics/Gynecology medical specialty as a personal lubricant device, intended to reduce friction during medical procedures or personal use in that clinical context.
How is KY Banksy Aloe supplied and is it sterile or single-use?
The device data does not specify sterility, single-use status, or supply format; therefore, no details about packaging, sterility, or reuse can be derived from the provided information.
What regulatory pathway was used for KY Banksy Aloe's clearance?
KY Banksy Aloe received FDA 510(k) clearance through the Traditional pathway, as indicated by the clearance_type field in the device data, following a 140-day review after submission on November 27, 2018.
What is the FDA classification and product code for KY Banksy Aloe?
KY Banksy Aloe is classified as a Class II device under regulation number 884.5300 with product code NUC, as explicitly stated in the device name and openfda fields.
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: K183302 FDA 510 (k) - KY Banksy Aloe | Rb Health (Us), LLC, KY Banksy Aloe (K183302) — FDA 510(k) | Innolitics, KY Banksy Aloe — FDA 510 (k) K183302 | MedTracker, KY Banksy Aloe 510 (k) K183302 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183302 | Class II | Active |
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Manufacturer
- Manufacturer
- RB Health (us) LLC
- FDA Applicant
- Rb Health (Us), LLC
Sources (1)
- FDA 510(k) K183302 24 fields · synced Oct 6, 2026