INTRAARC DRIVE SYSTEM— 510(k) K951263

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K951263 for INTRAARC DRIVE SYSTEM, Substantially Equivalent on 1995-04-17. Applicant: Linvatec Corp..

Clearance details

Applicant: Linvatec Corp.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1995-03-21
Decision date: 1995-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, 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.