INSTRUMENT STERILIZATION TRAY— 510(k) K863726

Name: FDA 510(k) clearance K863726
Creator: U.S. Food and Drug Administration
Published: 1986-10-14

Substantially Equivalent

Medical Technology Development Corp.

FDA 510(k) clearance K863726 for INSTRUMENT STERILIZATION TRAY, Substantially Equivalent on 1986-10-14. Applicant: Medical Technology Development Corp.. Device class: 1.

Clearance details

Applicant: Medical Technology Development Corp.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-09-23
Decision date: 1986-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, 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 Medical Technology Development Corp.

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K941488 — DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER1994-11-30
K862315 — FYODOROV COLLAGEN CORNEAL SHIELD1987-01-07
K863725 — CATARACT DIAMOND KNIFE1986-10-31
K863727 — FIXATION INSTRUMENTS1986-10-31

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.