PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM— 510(k) K880150

Name: FDA 510(k) clearance K880150
Creator: U.S. Food and Drug Administration
Published: 1988-03-04

Substantially Equivalent

Dyonics, Inc.

FDA 510(k) clearance K880150 for PACESETTER (TM) 3500 ARTHROSCOPIC SURGICAL SYSTEM, Substantially Equivalent on 1988-03-04. Applicant: Dyonics, Inc.. Device class: 1.

Clearance details

Applicant: Dyonics, Inc.
Product code: Code HWE
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1988-01-13
Decision date: 1988-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HWE

product code HWE

Death: 4
Injury: 448
Malfunction: 19,856
Other: 2
Total: 20,310

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.