INTERNAL HYDRATING GEL— 510(k) K141718

Substantially Equivalent

Combe Incorporated

FDA 510(k) clearance K141718 for INTERNAL HYDRATING GEL, Substantially Equivalent on 2014-11-13. Applicant: Combe Incorporated.

Clearance details

Applicant: Combe Incorporated
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2014-06-25
Decision date: 2014-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NUC

product code NUC

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.