PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM— 510(k) K964879

Name: FDA 510(k) clearance K964879
Creator: U.S. Food and Drug Administration
Published: 1997-03-04

Substantially Equivalent

Davol Inc., Sub. C. R. Bard, Inc.

FDA 510(k) clearance K964879 for PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED IRRIGATOR SYSTEM, Substantially Equivalent on 1997-03-04. Applicant: Davol Inc., Sub. C. R. Bard, Inc.. Device class: 2.

Clearance details

Applicant: Davol Inc., Sub. C. R. Bard, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1996-12-05
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canston, RI, 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.