Zenflow Spring Scope— 510(k) K251140
Substantially EquivalentZenflow, Inc.
FDA 510(k) clearance K251140 for Zenflow Spring Scope, Substantially Equivalent on 2025-09-23. Applicant: Zenflow, Inc.. Device class: 2.
Clearance details
- Applicant
- Zenflow, Inc.
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Francisco, CA, US
Recent devices under product code FAJ
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- K260271 — Strauss Surgical cystoscope, hysteroscope and accessories Instruments
Adverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
Source: openFDA MAUDE database, through . 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.