MSI SURGI-GRADE UNIVERSAL TRACH TRAY— 510(k) K843561

Name: FDA 510(k) clearance K843561
Creator: U.S. Food and Drug Administration
Published: 1984-10-24

Substantially Equivalent

Medical Sterilization, Inc.

FDA 510(k) clearance K843561 for MSI SURGI-GRADE UNIVERSAL TRACH TRAY, Substantially Equivalent on 1984-10-24. Applicant: Medical Sterilization, Inc.. Device class: 1.

Clearance details

Applicant: Medical Sterilization, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-09-10
Decision date: 1984-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSM

view all

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 Medical Sterilization, Inc.

view all

K984422 — STERILE BACK SURGICAL GOWN WITH HAND TOWEL1999-04-02
K912803 — MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL1992-01-10
K843564 — MSI SURGI-GRADE SUTURE TRAY1984-10-31
K843562 — MSI SURGI-GRADE DELUXE CUT-DOWN TRAY1984-10-24
K843563 — MSI SURGI-GRADE INCISION & DRAIN TRAY1984-10-23

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.