BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR— 510(k) K092144
Substantially EquivalentEndochoice, Inc.
FDA 510(k) clearance K092144 for BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR, Substantially Equivalent on 2010-02-22. Applicant: Endochoice, Inc.. Device class: 2.
Clearance details
- Applicant
- Endochoice, Inc.
- Product code
- 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
- Chalotte, NC, 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
More clearances from Endochoice, Inc.
view allAdverse 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.