HANDI-TRAY— 510(k) K823438

Name: FDA 510(k) clearance K823438
Creator: U.S. Food and Drug Administration
Published: 1983-01-14

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K823438 for HANDI-TRAY, Substantially Equivalent on 1983-01-14. Applicant: Treace Medical, Inc.. Device class: 1.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1982-11-16
Decision date: 1983-01-14
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 Treace Medical, Inc.

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K883727 — BUCKET PROSTHESIS PORP1989-01-13
K882349 — MALLET, SURGICAL1988-06-23
K874779 — BIPOLATOR 501988-01-29
K873154 — TREACE MAGNUM OTO-TOOL SYSTEM1987-09-04
K872000 — EYE GARD1987-07-21

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.