INSTRUMENT TRAY— 510(k) K772266

Name: FDA 510(k) clearance K772266
Creator: U.S. Food and Drug Administration
Published: 1978-01-20

Substantially Equivalent

Med Fusion Systems, Inc.

FDA 510(k) clearance K772266 for INSTRUMENT TRAY, Substantially Equivalent on 1978-01-20. Applicant: Med Fusion Systems, Inc.. Device class: 1.

Clearance details

Applicant: Med Fusion Systems, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-12-09
Decision date: 1978-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSM

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K971217 — INSTRUMENT TRAY LINER1997-05-06
K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

More clearances from Med Fusion Systems, Inc.

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K873961 — INFUMED 300 AMBULATORY INFUSION PUMP1987-12-29
K870524 — AMBULATORY INFUSION PUMP DRUG RESERVOIR1987-05-06
K870907 — INTRODUCER, PERCUTANEOUS1987-04-09
K864407 — REFILLABLE SYRINGE1987-01-20
K863814 — BAG SPIKE EXTENSION SET1986-10-14

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.