HU-FRIEDY IMS CASSETTE SYSTEM— 510(k) K844002

Name: FDA 510(k) clearance K844002
Creator: U.S. Food and Drug Administration
Published: 1984-11-08

Substantially Equivalent

Hu-Friedy Mfg. Co., Inc.

FDA 510(k) clearance K844002 for HU-FRIEDY IMS CASSETTE SYSTEM, Substantially Equivalent on 1984-11-08. Applicant: Hu-Friedy Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: Hu-Friedy Mfg. Co., Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-10-12
Decision date: 1984-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

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Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.