RESPONDER® Polysaccharide Hemostat— 510(k) K240454

Name: FDA 510(k) clearance K240454
Creator: U.S. Food and Drug Administration
Published: 2024-03-15

Substantially Equivalent

Starch Medical, Inc.

FDA 510(k) clearance K240454 for RESPONDER® Polysaccharide Hemostat, Substantially Equivalent on 2024-03-15. Applicant: Starch Medical, Inc.. Device class: Unclassified.

Clearance details

Applicant: Starch Medical, Inc.
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2024-02-15
Decision date: 2024-03-15
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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K220525 — RESPONDER Polysaccharide Hemostat2023-12-04

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.