ACE SYSTEM— 510(k) K960853

Name: FDA 510(k) clearance K960853
Creator: U.S. Food and Drug Administration
Published: 1996-04-03

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K960853 for ACE SYSTEM, Substantially Equivalent on 1996-04-03. Applicant: Xomed, Inc.. Device class: 1.

Clearance details

Applicant: Xomed, Inc.
Product code: Code EQJ
Device class: Class 1
Regulation: 21 CFR 874.4140
Advisory panel: Ear, Nose, Throat
Date received: 1996-03-01
Decision date: 1996-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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K002828 — XPS NITRO SYSTEM2000-10-17
K002897 — TITANIUM MIDDLE EAR PROSTHESES2000-10-11
K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES2000-06-09

Adverse events under product code EQJ

product code EQJ

Malfunction: 1,552
Total: 1,552

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.