Home › Device types › MQR
Stent, Colonic, Metallic, Expandable
FDA product code MQR · Class 2 · General, Plastic Surgery
76
Registered devices
1,327
Adverse events
2
Recalls
16
510(k) clearances
Devices with this code
WallFlex™ Colonic — BOSTON SCIENTIFIC CORPORATIONWALLSTENT™ BILIARY — BOSTON SCIENTIFIC CORPORATIONADD — Ulrich GmbH & Co. KGHANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.WALLSTENT™ Enteral Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONNiti-S Colonic Comfort Stent — TAEWOONGMEDICAL.CO.,LTDHANAROSTENT LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.WALLSTENT™ Enteral Endoprosthesis — BOSTON SCIENTIFIC CORPORATIONHANAROSTENT LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.HANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.WallFlex™ Colonic — BOSTON SCIENTIFIC CORPORATIONEvolution — COOK IRELAND LTDHANAROSTENT LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.Niti-S Colonic Comfort Stent — TAEWOONGMEDICAL.CO.,LTDHANAROSTENT LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.HANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.WallFlex™ Colonic — BOSTON SCIENTIFIC CORPORATIONHANAROSTENT LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.Niti-S Colonic Comfort Stent — TAEWOONGMEDICAL.CO.,LTDHANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.HANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.HANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.HANAROSTENT® LowAxTM Colon/Rectum(NNN) — M.I.Tech Co., Ltd.WallFlex™ Colonic — BOSTON SCIENTIFIC CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the |
| 2010-07-15 | Boston Scientific Corporation | Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment. |
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