RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)— 510(k) K884250

Substantially Equivalent

Mentor Corp.

FDA 510(k) clearance K884250 for RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.), Substantially Equivalent on 1989-06-12. Applicant: Mentor Corp..

Clearance details

Applicant: Mentor Corp.
Product code: Code LCJ
Advisory panel: Unknown
Date received: 1988-10-11
Decision date: 1989-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, 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.