FDA 510(k)

SafePort(TM) Manifold (or Stopcock)

K-Number: K211204 · 2022-09-15

Decision Date2022-09-15

Product CodeFMG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SafePort(TM) Manifold (or Stopcock) is a medical device manufactured by Elcam Medical Acal. It received FDA 510(k) clearance on 2022-09-15 under approval number K211204. The device is classified under product code FMG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SafePort(TM) Manifold (or Stopcock)?

SafePort(TM) Manifold (or Stopcock) is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Elcam Medical Acal. The 510(k) number is K211204.

When was SafePort(TM) Manifold (or Stopcock) approved by the FDA?

SafePort(TM) Manifold (or Stopcock) received FDA 510(k) clearance on 2022-09-15, under approval number K211204.

What company makes SafePort(TM) Manifold (or Stopcock)?

SafePort(TM) Manifold (or Stopcock) is manufactured by Elcam Medical Acal.

What is the FDA product code for SafePort(TM) Manifold (or Stopcock)?

The FDA product code for SafePort(TM) Manifold (or Stopcock) is FMG.

Other Devices by Elcam Medical Acal

K190489Elcam Stopcocks and Manifolds K231900A-TAP (previously called Arthrotap)

Related Devices (Code: FMG)

K172266Dynarex Three-Way StopcockDynarex Corporation K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLC K190489Elcam Stopcocks and ManifoldsElcam Medical Acal K210516Clicky CrossYomura Technologies, Inc. K223499Three Way Stop CockM/S Romsons International K223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.