MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE— 510(k) K983297
Substantially EquivalentMedtronic 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.. Device class: 2.
Clearance details
- Applicant
- Medtronic Instent, Inc.
- Product code
- Product code ESW
- Device class
- Class 2
- Regulation
- 21 CFR 878.3610
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code ESW
view all- K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System
- K243619 — Niti-S Esophageal Stent; Esophageal TTS Stent
- K253327 — HANAROSTENT Esophagus Upper (CCC)
- K251265 — Resilience Fully Covered Esophageal Stent System
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
Adverse events under product code ESW
product code ESW- Death
- 11
- Injury
- 353
- Malfunction
- 442
- Total
- 806
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.