FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM— 510(k) K050575

Name: FDA 510(k) clearance K050575
Creator: U.S. Food and Drug Administration
Published: 2005-08-15

Substantially Equivalent

Futumeds Sdn Bhd

FDA 510(k) clearance K050575 for FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM, Substantially Equivalent on 2005-08-15. Applicant: Futumeds Sdn Bhd. Device class: 1.

Clearance details

Applicant: Futumeds Sdn Bhd
Product code: Code MDM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 2005-03-07
Decision date: 2005-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Puchong, MY

Download summary PDF View on FDA.gov ↗

Recent devices under product code MDM

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K073664 — FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER2008-08-08
K050957 — EUTROCHAR2005-05-18
K023173 — ANDREWS INTRODUCER, MODEL ASI012002-12-18
K022059 — MICROVASIVE PULMONARY GUIDEWIRE2002-11-13
K013040 — LIGHT SABER INTRODUCER NEEDLE2001-12-07

Adverse events under product code MDM

product code MDM

Injury: 247
Malfunction: 1,516
Total: 1,763

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.