MICRO-SUGICAL POWER INSTRUMENT SYSTEM— 510(k) K802503

Name: FDA 510(k) clearance K802503
Creator: U.S. Food and Drug Administration
Published: 1980-10-31

Substantially Equivalent

Spire Medical, Inc.

FDA 510(k) clearance K802503 for MICRO-SUGICAL POWER INSTRUMENT SYSTEM, Substantially Equivalent on 1980-10-31. Applicant: Spire Medical, Inc.. Device class: 1.

Clearance details

Applicant: Spire Medical, Inc.
Product code: Code EQJ
Device class: Class 1
Regulation: 21 CFR 874.4140
Advisory panel: Ear, Nose, Throat
Date received: 1980-10-17
Decision date: 1980-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spire Medical, Inc.

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K821487 — MICRO-SURGICAL POWER INSTRUMENT SYS.1982-07-02
K821485 — DERMABRADERS1982-06-10
K821486 — MICRO DRILLS1982-06-09
K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM1980-10-31

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.