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EndoClot SIS
EndoClot Plus Co.,Ltd. · Model SIS-30-01 · UDI-DI 16972011720240
PLL
Prescription
1
510(k) clearances
70
Adverse events
1
Recalls
13
Facilities
Description
EndoClot Submucosal Injection System
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 reaction to remnant ORl |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.