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Submucosal Injection Agent
FDA product code PLL · Class 2 · Gastroenterology, Urology
22
Registered devices
70
Adverse events
1
Recalls
9
510(k) clearances
Devices with this code
EndoClot — EndoClot Plus Co.,Ltd.EndoClot — EndoClot Plus Co.,Ltd.ASCENDO submucosal lifting agent — US EndoscopyLiftUp Kit — Ovesco Endoscopy AGBlueBoost(TM) Submucosal Injectable Solution — Micro-Tech (Nanjing) Co., Ltd.BlueBoost(TM) Submucosal Injectable Solution — Micro-Tech (Nanjing) Co., Ltd.Blue Eye — THE STANDARD CO.,LTD.Eleview 5mL — COSMO TECHNOLOGIES LIMITEDORISE™ Gel — BOSTON SCIENTIFIC CORPORATIONAscendo — US EndoscopyEverLift — GI Supply, Inc.Eleview — COSMO TECHNOLOGIES LIMITEDBlue Eye — THE STANDARD CO.,LTD.ORISE™ Gel — BOSTON SCIENTIFIC CORPORATIONORISE™ Gel — BOSTON SCIENTIFIC CORPORATIONEleview — COSMO TECHNOLOGIES LIMITEDEndoClot SIS — EndoClot Plus Co.,Ltd.EverLift — GI Supply, Inc.LiftUp — Ovesco Endoscopy AGORISE™ Gel — BOSTON SCIENTIFIC CORPORATIONEndoClot SIS — EndoClot Plus Co.,Ltd.Eleview — COSMO TECHNOLOGIES LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-10 | Boston Scientific Corporation | ***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions*** Potential outcomes associated with foreign body rea |
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