LYSONIX IRRIGATION SYSTEM— 510(k) K974233

Name: FDA 510(k) clearance K974233
Creator: U.S. Food and Drug Administration
Published: 1998-02-03

Substantially Equivalent

Lysonix, Inc.

FDA 510(k) clearance K974233 for LYSONIX IRRIGATION SYSTEM, Substantially Equivalent on 1998-02-03. Applicant: Lysonix, Inc.. Device class: 1.

Clearance details

Applicant: Lysonix, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1997-11-12
Decision date: 1998-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carpinteria, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Lysonix, Inc.

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K980771 — LYSONIX SUCTION LIPOPLASTY SYSTEM1998-07-13
K980763 — LYSONIX LIPOPLASTY ACCESS PORT1998-05-28
K980454 — LYSONIX ASPIRATION PUMP1998-03-18
K972958 — LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS1997-09-19

Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.