FIXATION STYLETS, MODELS 335-287 AND 335-288— 510(k) K000366

Name: FDA 510(k) clearance K000366
Creator: U.S. Food and Drug Administration
Published: 2000-04-14

Substantially Equivalent

Accufix Research Institute

FDA 510(k) clearance K000366 for FIXATION STYLETS, MODELS 335-287 AND 335-288, Substantially Equivalent on 2000-04-14. Applicant: Accufix Research Institute. Device class: 2.

Clearance details

Applicant: Accufix Research Institute
Product code: Code DRB
Device class: Class 2
Regulation: 21 CFR 870.1380
Advisory panel: Cardiovascular
Date received: 2000-02-04
Decision date: 2000-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRB

product code DRB

Death: 36
Injury: 562
Total: 598

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.