CHESS HAND SURGERY SYSTEM— 510(k) K010184

Name: FDA 510(k) clearance K010184
Creator: U.S. Food and Drug Administration
Published: 2001-06-22

Substantially Equivalent

Canica Design, Inc.

FDA 510(k) clearance K010184 for CHESS HAND SURGERY SYSTEM, Substantially Equivalent on 2001-06-22. Applicant: Canica Design, Inc.. Device class: 1.

Clearance details

Applicant: Canica Design, Inc.
Product code: Code MDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2001-01-19
Decision date: 2001-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Almonte, Ontario, CA

Download summary PDF View on FDA.gov ↗

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K023173 — ANDREWS INTRODUCER, MODEL ASI012002-12-18
K022059 — MICROVASIVE PULMONARY GUIDEWIRE2002-11-13

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.