SafePort(TM) Manifold (or Stopcock)— 510(k) K211204

Name: FDA 510(k) clearance K211204
Creator: U.S. Food and Drug Administration
Published: 2022-09-15

Substantially Equivalent

Elcam Medical Acal

FDA 510(k) clearance K211204 for SafePort(TM) Manifold (or Stopcock), Substantially Equivalent on 2022-09-15. Applicant: Elcam Medical Acal. Device class: 2.

Clearance details

Applicant: Elcam Medical Acal
Product code: Code FMG
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 2021-04-22
Decision date: 2022-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baram, IL

Download summary PDF View on FDA.gov ↗

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K231900 — A-TAP (previously called Arthrotap)2023-07-25
K190489 — Elcam Stopcocks and Manifolds2019-04-23
K141254 — ELCAM STOPCOCKS AND MANIFOLDS2014-07-30
K123084 — DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD2013-05-23
K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)2012-07-16

Adverse events under product code FMG

product code FMG

Death: 14
Malfunction: 3,433
Other: 1
Total: 3,448

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.