SYLK PERSONAL LUBRICANT— 510(k) K152646

Substantially Equivalent

Toro Management, LLC Dba Sylk

FDA 510(k) clearance K152646 for SYLK PERSONAL LUBRICANT, Substantially Equivalent on 2016-03-11. Applicant: Toro Management, LLC Dba Sylk.

Clearance details

Applicant: Toro Management, LLC Dba Sylk
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2015-09-16
Decision date: 2016-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, 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.