DISPOSABLE NEEDLE HOLDERS— 510(k) K821618

Substantially Equivalent

Medcare Products

FDA 510(k) clearance K821618 for DISPOSABLE NEEDLE HOLDERS, Substantially Equivalent on 1982-06-21. Applicant: Medcare Products.

Clearance details

Applicant: Medcare Products
Product code: Code FZX
Advisory panel: General, Plastic Surgery
Date received: 1982-06-02
Decision date: 1982-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FZX

product code FZX

Injury: 797
Malfunction: 3,815
Total: 4,612

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.