CASF STERILIZATION TRAY— 510(k) K883125

Name: FDA 510(k) clearance K883125
Creator: U.S. Food and Drug Administration
Published: 1988-08-10

Substantially Equivalent

Terray Manufacturing, Inc.

FDA 510(k) clearance K883125 for CASF STERILIZATION TRAY, Substantially Equivalent on 1988-08-10. Applicant: Terray Manufacturing, Inc.. Device class: 1.

Clearance details

Applicant: Terray Manufacturing, Inc.
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-07-26
Decision date: 1988-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario K7s 1l8, CA

Download summary PDF View on FDA.gov ↗

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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 Terray Manufacturing, Inc.

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K910874 — THORACIC ANTERIOR SPINAL FIXATION PLATE1992-02-03
K882934 — CASF CANCELLOUS BONE SCREW, BT6501988-10-13
K882871 — CASF DRILL GUIDE DG 1701988-09-23
K883193 — CASF STERILIZATION TRAY1988-08-10
K870085 — ANTERIOR SPINAL FIXATION PLATE1987-06-30

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.