Intimol
510(k) K061466
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061466 | Date4 Dec 2006 | StatusActive |
Official records
- FDA 510(k) database K061466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NUC
- Device class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
Intimol is a personal lubricant classified as an obstetrics and gynecology device. It is designed to provide lubrication for personal use.
This device is regulated under FDA 510(k) clearance number K061466. It is categorized as a Class 2 medical device.
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