SURGITEK(R) EXTERNAL FILL PORT— 510(k) K894495

Substantially Equivalent

Surgitek

FDA 510(k) clearance K894495 for SURGITEK(R) EXTERNAL FILL PORT, Substantially Equivalent on 1990-01-17. Applicant: Surgitek.

Clearance details

Applicant: Surgitek
Product code: Code LCJ
Advisory panel: Unknown
Date received: 1989-07-19
Decision date: 1990-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

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Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

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.