SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER— 510(k) K903448

Substantially Equivalent

Medical Engineering Corp.

FDA 510(k) clearance K903448 for SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER, Substantially Equivalent on 1991-01-14. Applicant: Medical Engineering Corp..

Clearance details

Applicant: Medical Engineering Corp.
Product code: Code LCJ
Advisory panel: Unknown
Date received: 1990-07-31
Decision date: 1991-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paso Robles, CA, 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.