MICRO-SURGICAL POWER INSTRUMENT SYSTEM— 510(k) K802463

Substantially Equivalent

Spire Medical, Inc.

FDA 510(k) clearance K802463 for MICRO-SURGICAL POWER INSTRUMENT SYSTEM, Substantially Equivalent on 1980-10-31. Applicant: Spire Medical, Inc..

Clearance details

Applicant: Spire Medical, Inc.
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 1980-10-09
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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.