Device class
Class II
Regulation 884.5300
Total clearances
3
2020-07-23 → 2022-02-11
Definition
What is Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples trying to conceive. This device may also be used during fertility interventions to facilitate entry of diagnostic and therapeutic devices.
Classification details
Medical specialty
Obstetrics/Gynecology
Regulation number
884.5300
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| A4322 |
HCPCS
|
Irrigation syringe, bulb or piston, each ✓ CMS-verified description |
High
|
Lubricant, personal use; gamete and embryo-compatible contraceptive supply |
Pulse
Most recent 510(k) clearances