ALLOX2 TISSUE EXPANDERS— 510(k) K140383

Substantially Equivalent

Specialty Surgical Products, Inc.

FDA 510(k) clearance K140383 for ALLOX2 TISSUE EXPANDERS, Substantially Equivalent on 2014-10-28. Applicant: Specialty Surgical Products, Inc..

Clearance details

Applicant: Specialty Surgical Products, Inc.
Product code: Code LCJ
Advisory panel: Unknown
Date received: 2014-02-14
Decision date: 2014-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victor, MT, 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.