OPERATING ROOM TRAY SET— 510(k) K840021

Name: FDA 510(k) clearance K840021
Creator: U.S. Food and Drug Administration
Published: 1984-03-15

Substantially Equivalent

Medi-Plast Intl., Inc.

FDA 510(k) clearance K840021 for OPERATING ROOM TRAY SET, Substantially Equivalent on 1984-03-15. Applicant: Medi-Plast Intl., Inc.. Device class: 1.

Clearance details

Applicant: Medi-Plast Intl., Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-01-05
Decision date: 1984-03-15
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 Medi-Plast Intl., Inc.

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K954284 — MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON)1996-02-12
K873588 — 10CC CONTROL SYRINGE1987-10-23
K863402 — MEDI-PLAST DISPOSABLE MANIFOLD1986-10-22
K861785 — FLUOROSCOPE BAND BAG1986-06-13
K851489 — ARTERIAL-VENOUS COMPRESSION DRESSING1985-06-11

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.