MITEK STERILIZATION TRAY— 510(k) K893886

Name: FDA 510(k) clearance K893886
Creator: U.S. Food and Drug Administration
Published: 1989-08-21

Substantially Equivalent

Mitek Surgical Products, Inc.

FDA 510(k) clearance K893886 for MITEK STERILIZATION TRAY, Substantially Equivalent on 1989-08-21. Applicant: Mitek Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Mitek Surgical Products, Inc.
Product code: Code FLE
Device class: Class 2
Regulation: 21 CFR 880.6880
Advisory panel: General Hospital
Date received: 1989-05-30
Decision date: 1989-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dedham, MA, US

Download summary PDF View on FDA.gov ↗

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K953560 — MITEK THREADED ANCHOR (FASTIN)1996-01-31
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K936311 — MITEK MINI ANCHOR1995-10-31
K941599 — MITEK ABSORBABLE ANCHOR1995-10-24
K944051 — ABSORBALBE ANCHOR1995-08-02

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.