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FDA 510(k)

SafePort(TM) Manifold (or Stopcock)

K-Number: K211204 · 2022-09-15

ApplicantElcam Medical Acal
Decision Date2022-09-15
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SafePort(TM) Manifold (or Stopcock) is the device name listed in this FDA 510(k) record. The listed applicant is Elcam Medical Acal. It received FDA 510(k) clearance on 2022-09-15 under 510(k) 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. The listed applicant is Elcam Medical Acal. The 510(k) number is K211204.

When did SafePort(TM) Manifold (or Stopcock) receive FDA 510(k) clearance?

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

Who is the listed applicant for SafePort(TM) Manifold (or Stopcock)?

The FDA 510(k) record lists Elcam Medical Acal as the applicant. This does not by itself establish the device manufacturer.

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 records listing Elcam Medical Acal as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: FMG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242255Qitexio® 4-Way Stopcock (QIT014)MedexK223499Three Way Stop CockM/S Romsons InternationalK223175lntravascular Administration Sets with Stopcock and ManifoldBaxter Healthcare CorporationK210516Clicky CrossYomura Technologies, Inc.K190539TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non SterileMonumedical, LLCK190489Elcam Stopcocks and ManifoldsElcam Medical Acal

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.

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