RAIL CLAMP EXTENSION PIECE— 510(k) K864459

Name: FDA 510(k) clearance K864459
Creator: U.S. Food and Drug Administration
Published: 1986-12-01

Substantially Equivalent

American Container Technology, Inc.

FDA 510(k) clearance K864459 for RAIL CLAMP EXTENSION PIECE, Substantially Equivalent on 1986-12-01. Applicant: American Container Technology, Inc.. Device class: 1.

Clearance details

Applicant: American Container Technology, Inc.
Product code: Code FWZ
Device class: Class 1
Regulation: 21 CFR 878.4950
Advisory panel: General, Plastic Surgery
Date received: 1986-11-12
Decision date: 1986-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallington, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FWZ

product code FWZ

Malfunction: 932
Other: 1
Total: 933

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.