Soft Plug Extended Duration 180 Canalicular Plug— 510(k) K162361

Substantially Equivalent

Oasis Medical, Inc.

FDA 510(k) clearance K162361 for Soft Plug Extended Duration 180 Canalicular Plug, Substantially Equivalent on 2017-04-17. Applicant: Oasis Medical, Inc..

Clearance details

Applicant: Oasis Medical, Inc.
Product code: Code LZU
Advisory panel: Unknown
Date received: 2016-08-23
Decision date: 2017-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LZU

product code LZU

Other: 2
Total: 2

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.