JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
FDA 510(k) clearance K230674 · decided 2023-05-08
Clearance details
- K-number
- K230674
- Device name
- JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114
- Applicant
- CC Wellness, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-03-10
- Decision date
- 2023-05-08
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- NUC
- Device class
- 2
- Regulation number
- 884.5300
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Valencia, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch CC Wellness
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.