Tembo Embolic System— 510(k) K253677

Substantially Equivalent

Instylla, Inc.

FDA 510(k) clearance K253677 for Tembo Embolic System, Substantially Equivalent on 2025-12-15. Applicant: Instylla, Inc..

Clearance details

Applicant: Instylla, Inc.
Product code: Code KRD
Advisory panel: Cardiovascular
Date received: 2025-11-21
Decision date: 2025-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KRD

product code KRD

Death: 119
Injury: 1,869
Malfunction: 7,015
Other: 1
Total: 9,004

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.