MEDELA THOPAZ, MODEL 200 0288— 510(k) K080212

Substantially Equivalent

Medela AG

FDA 510(k) clearance K080212 for MEDELA THOPAZ, MODEL 200 0288, Substantially Equivalent on 2008-07-23. Applicant: Medela AG.

Clearance details

Applicant: Medela AG
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2008-01-29
Decision date: 2008-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar Zug, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.