XOMED TRANSSPHENOIDAL HANDPIECE— 510(k) K781418

Name: FDA 510(k) clearance K781418
Creator: U.S. Food and Drug Administration
Published: 1978-08-31

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K781418 for XOMED TRANSSPHENOIDAL HANDPIECE, Substantially Equivalent on 1978-08-31. Applicant: Xomed, Inc.. Device class: 2.

Clearance details

Applicant: Xomed, Inc.
Product code: Code ERL
Device class: Class 2
Regulation: 21 CFR 874.4250
Advisory panel: Ear, Nose, Throat
Date received: 1978-08-16
Decision date: 1978-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arnold, MO, 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
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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.