DeviceClearance

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1) +2 more— 510(k) K260909

Substantially Equivalent

Sienco, Inc.

FDA 510(k) clearance K260909 for Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1) +2 more, Substantially Equivalent on 2026-10-27. Applicant: Sienco, Inc.. Device class: 2.

Clearance details

Device name as filed
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (SCP1); Sonoclot Coagulation & Platelet Function Analzyer System with Sonoclot Viewer (SCP2); Sonoclot Coagulation Analyzer System with Sonoclot Viewer (SC1)
Applicant
Sienco, Inc.
Product code
Product code JPA
Device class
Class 2
Regulation
21 CFR 864.5425
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code JPA

product code JPA
Death
6
Total
6

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.