CODMAN SOFWIRE(TM) KIT— 510(k) K926116

Substantially Equivalent

Codman & Shurtleff, Inc.

FDA 510(k) clearance K926116 for CODMAN SOFWIRE(TM) KIT, Substantially Equivalent on 1993-03-30. Applicant: Codman & Shurtleff, Inc..

Clearance details

Applicant: Codman & Shurtleff, Inc.
Product code: Code JDQ
Advisory panel: Orthopedic
Date received: 1992-12-03
Decision date: 1993-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, MA, US

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Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.