Ancora-SB— 510(k) K260314

Name: FDA 510(k) clearance K260314
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Substantially Equivalent

Aspero Medical, Inc.

FDA 510(k) clearance K260314 for Ancora-SB, Substantially Equivalent on 2026-05-01. Applicant: Aspero Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aspero Medical, Inc.
Product code: Code FDA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-01-30
Decision date: 2026-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FDA

product code FDA

Death: 8
Injury: 148
Total: 156

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.