AREOLA/NIPPLE DRESSING— 510(k) K882558

Substantially Equivalent

Cooper Surgical/Aesthete

FDA 510(k) clearance K882558 for AREOLA/NIPPLE DRESSING, Substantially Equivalent on 1989-05-24. Applicant: Cooper Surgical/Aesthete.

Clearance details

Applicant: Cooper Surgical/Aesthete
Product code: Code NAD
Advisory panel: General, Plastic Surgery
Date received: 1988-06-21
Decision date: 1989-05-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paso Robles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NAD

product code NAD

Injury: 431
Malfunction: 11,935
Other: 1
Total: 12,367

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.