INSTRUMENT TRAY LINER— 510(k) K971217

Name: FDA 510(k) clearance K971217
Creator: U.S. Food and Drug Administration
Published: 1997-05-06

Substantially Equivalent

General Hospital Supply Corp.

FDA 510(k) clearance K971217 for INSTRUMENT TRAY LINER, Substantially Equivalent on 1997-05-06. Applicant: General Hospital Supply Corp.. Device class: 1.

Clearance details

Applicant: General Hospital Supply Corp.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1997-04-02
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilton, CT, US

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Recent devices under product code FSM

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K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26
K912052 — HEART CATH TRAY1991-08-20

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.