DeviceClearance

POREX(TM) TISSUE EXPANDER— 510(k) K870154

Substantially Equivalent

Porex Medical

FDA 510(k) clearance K870154 for POREX(TM) TISSUE EXPANDER, Substantially Equivalent on 1987-02-24. Applicant: Porex Medical.

Clearance details

Applicant
Porex Medical
Product code
Code LCJ
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fairburn, GA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LCJ

product code LCJ
Injury
2,704
Other
2
Total
2,706

Source: openFDA MAUDE database, through . 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.