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— 510(k) K230674

Clearance details

Applicant

CC Wellness, LLC

Product code

Code NUC

Device class

Class 2

Regulation

21 CFR 884.5300

Advisory panel

Obstetrics/Gynecology

Date received

2023-03-10

Decision date

2023-05-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Valencia, CA, US

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Other

8

Total

8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →