GYRUS PLASMA SKIN RESURFACING SYSTEM— 510(k) K023111

Name: FDA 510(k) clearance K023111
Creator: U.S. Food and Drug Administration
Published: 2003-03-13

Substantially Equivalent

Gyrus Medical, Inc.

FDA 510(k) clearance K023111 for GYRUS PLASMA SKIN RESURFACING SYSTEM, Substantially Equivalent on 2003-03-13. Applicant: Gyrus Medical, Inc.. Device class: 2.

Clearance details

Applicant: Gyrus Medical, Inc.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2002-09-19
Decision date: 2003-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gyrus Medical, Inc.

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K050550 — GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR2005-11-09
K050460 — GYRUS PLASMACISION AND PLASMABLEND ELECTRODES2005-10-25
K041999 — GYRUS PLASMA SKIN RESURFACING SYSTEM2005-03-02
K041633 — GYRUS PLASMACISION LAPAROSCOPIC SPATULA2004-10-22
K024286 — GYRUS OPEN FORCEPS2003-11-17

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.