Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
FDA 510(k) clearance K234099 · decided 2024-06-07
Clearance details
- K-number
- K234099
- Device name
- Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant
- Applicant
- Select Labs, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-12-26
- Decision date
- 2024-06-07
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Charlotte, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Select Labs
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.