X-PAK— 510(k) K791917

Substantially Equivalent

Contemporary Surgical Systems, Inc.

FDA 510(k) clearance K791917 for X-PAK, Substantially Equivalent on 1979-10-30. Applicant: Contemporary Surgical Systems, Inc..

Clearance details

Applicant: Contemporary Surgical Systems, Inc.
Product code: Code HMX
Advisory panel: Ophthalmic
Date received: 1979-09-25
Decision date: 1979-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HMX

product code HMX

Other: 1
Total: 1

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.