ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183— 510(k) K023777

Name: FDA 510(k) clearance K023777
Creator: U.S. Food and Drug Administration
Published: 2002-12-11

Substantially Equivalent

Arthronet Medical, Inc.

FDA 510(k) clearance K023777 for ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183, Substantially Equivalent on 2002-12-11. Applicant: Arthronet Medical, Inc.. Device class: 2.

Clearance details

Applicant: Arthronet Medical, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2002-11-12
Decision date: 2002-12-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.