INCL ENDOSCOPE— 510(k) K955471

Substantially Equivalent for Some Indications

Sofamor Danek USA,Inc.

FDA 510(k) clearance K955471 for INCL ENDOSCOPE, Substantially Equivalent for Some Indications on 1995-12-18. Applicant: Sofamor Danek USA,Inc..

Clearance details

Applicant: Sofamor Danek USA,Inc.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 1995-10-10
Decision date: 1995-12-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, 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.