Zenflow Spring Scope— 510(k) K251140

Substantially Equivalent

Zenflow, Inc.

FDA 510(k) clearance K251140 for Zenflow Spring Scope, Substantially Equivalent on 2025-09-23. Applicant: Zenflow, Inc..

Clearance details

Applicant: Zenflow, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2025-04-14
Decision date: 2025-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.