MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE— 510(k) K983297

Substantially Equivalent

Medtronic Instent, Inc.

FDA 510(k) clearance K983297 for MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE, Substantially Equivalent on 1998-12-18. Applicant: Medtronic Instent, Inc..

Clearance details

Applicant: Medtronic Instent, Inc.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 1998-09-21
Decision date: 1998-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ESW

product code ESW

Death: 11
Injury: 353
Malfunction: 442
Total: 806

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.