DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD— 510(k) K123084

Name: FDA 510(k) clearance K123084
Creator: U.S. Food and Drug Administration
Published: 2013-05-23

Substantially Equivalent

Elcam Medical Acal

FDA 510(k) clearance K123084 for DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD, Substantially Equivalent on 2013-05-23. 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: 2012-10-01
Decision date: 2013-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mp. Merom Hagalil, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMG

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K242255 — Qitexio® 4-Way Stopcock (QIT014)2025-04-29
K223499 — Three Way Stop Cock2023-07-21
K223175 — lntravascular Administration Sets with Stopcock and Manifold2023-03-10
K211204 — SafePort(TM) Manifold (or Stopcock)2022-09-15
K210516 — Clicky Cross2022-05-16

More clearances from Elcam Medical Acal

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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
K120253 — ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS)2012-07-16
K120624 — ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)2012-06-08

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.