COLLATEK HYDROGEL— 510(k) K022995

Name: FDA 510(k) clearance K022995
Creator: U.S. Food and Drug Administration
Published: 2002-12-02

Substantially Equivalent

Biocore Medical Technologies, Inc.

FDA 510(k) clearance K022995 for COLLATEK HYDROGEL, Substantially Equivalent on 2002-12-02. Applicant: Biocore Medical Technologies, Inc.. Device class: Unclassified.

Clearance details

Applicant: Biocore Medical Technologies, Inc.
Product code: Code MGQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 2002-09-09
Decision date: 2002-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Spring, MD, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.