STEERABLE STYLET— 510(k) K040001

Substantially Equivalent

Synovis Surgical Innovations

FDA 510(k) clearance K040001 for STEERABLE STYLET, Substantially Equivalent on 2004-03-09. Applicant: Synovis Surgical Innovations.

Clearance details

Applicant: Synovis Surgical Innovations
Product code: Code DRB
Advisory panel: Cardiovascular
Date received: 2004-01-02
Decision date: 2004-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.