HALL IRRIGATION SYSTEM— 510(k) K852143

Name: FDA 510(k) clearance K852143
Creator: U.S. Food and Drug Administration
Published: 1985-06-26

Substantially Equivalent

Hall Surgical, Division of Zimmer, Inc.

FDA 510(k) clearance K852143 for HALL IRRIGATION SYSTEM, Substantially Equivalent on 1985-06-26. Applicant: Hall Surgical, Division of Zimmer, Inc.. Device class: 1.

Clearance details

Applicant: Hall Surgical, Division of Zimmer, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1985-05-16
Decision date: 1985-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: `Anta Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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K942660 — HALL MICROCHOICE ELECTRIC POWERED SYSTEM1994-09-07
K864734 — HALL ORAL IMPLANT SYSTEM1987-02-10
K864929 — HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST1987-01-28
K864163 — HALL DUNBAR DRILL GUIDE SYSTEM1986-11-20
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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.