ADVANCED TRAUMA DRESSING (ATD)— 510(k) K101257

Substantially Equivalent

Nanosys, Inc.

FDA 510(k) clearance K101257 for ADVANCED TRAUMA DRESSING (ATD), Substantially Equivalent on 2011-12-01. Applicant: Nanosys, Inc..

Clearance details

Applicant: Nanosys, Inc.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2010-05-04
Decision date: 2011-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

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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.