BLACKSTAR(TM) STAR SYSTEM— 510(k) K945659

Substantially Equivalent

Xomed-Treace, Inc.

FDA 510(k) clearance K945659 for BLACKSTAR(TM) STAR SYSTEM, Substantially Equivalent on 1995-01-09. Applicant: Xomed-Treace, Inc..

Clearance details

Applicant: Xomed-Treace, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1994-11-17
Decision date: 1995-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

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Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.