MOLLI 2 System— 510(k) K253888

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K253888 for MOLLI 2 System, Substantially Equivalent on 2025-12-31. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2025-12-04
Decision date: 2025-12-31
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.