TRACHEOSTOMY CARE TRAY— 510(k) K841122

Name: FDA 510(k) clearance K841122
Creator: U.S. Food and Drug Administration
Published: 1984-04-25

Substantially Equivalent

Medcare Products

FDA 510(k) clearance K841122 for TRACHEOSTOMY CARE TRAY, Substantially Equivalent on 1984-04-25. Applicant: Medcare Products. Device class: 1.

Clearance details

Applicant: Medcare Products
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1984-03-15
Decision date: 1984-04-25
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 Medcare Products

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K841124 — DIALYSIS TRAY1984-04-20
K841123 — DRESSING CHANGE TRAY1984-04-17
K831374 — MED CARE PREP RAZOR1983-10-04
K831663 — TISSUE FORCEPS1983-09-26
K831664 — PLASTIC THUMB FORCEPS1983-09-12

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.