OFNat Lubricant (L15)— 510(k) K221243

Substantially Equivalent

Suretex Limited

FDA 510(k) clearance K221243 for OFNat Lubricant (L15), Substantially Equivalent on 2022-09-30. Applicant: Suretex Limited.

Clearance details

Applicant: Suretex Limited
Product code: Code NUC
Advisory panel: Obstetrics/Gynecology
Date received: 2022-05-02
Decision date: 2022-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tambon Khao Kwai, Amphur Phunphin, TH

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.