ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR)— 510(k) K901617

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K901617 for ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR), Substantially Equivalent on 1990-05-29. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1990-04-06
Decision date: 1990-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.