EBI VUECATH SPINAL ENDOSCOPIC SYSTEM— 510(k) K010179

Substantially Equivalent

Ebi, L.P.

FDA 510(k) clearance K010179 for EBI VUECATH SPINAL ENDOSCOPIC SYSTEM, Substantially Equivalent on 2001-02-09. Applicant: Ebi, L.P..

Clearance details

Applicant: Ebi, L.P.
Product code: Code HRX
Advisory panel: Orthopedic
Date received: 2001-01-19
Decision date: 2001-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Parsippany, NJ, 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.