DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.— 510(k) K883975

Substantially Equivalent

Site Microsurgical Systems, Inc.

FDA 510(k) clearance K883975 for DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI., Substantially Equivalent on 1988-10-25. Applicant: Site Microsurgical Systems, Inc..

Clearance details

Applicant: Site Microsurgical Systems, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1988-09-20
Decision date: 1988-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Horsham, PA, US

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.