MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM— 510(k) K973584

Substantially Equivalent

Medtech Instruments

FDA 510(k) clearance K973584 for MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM, Substantially Equivalent on 1998-01-09. Applicant: Medtech Instruments.

Clearance details

Applicant: Medtech Instruments
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 1997-09-22
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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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.