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FDA 510(k)

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile

K-Number: K190539 · 2019-10-22

ApplicantMonumedical, LLC
Decision Date2019-10-22
Product CodeFMG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Monumedical, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K190539. 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 TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Monumedical, LLC. The 510(k) number is K190539.

When did TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile receive FDA 510(k) clearance?

TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile received FDA 510(k) clearance on 2019-10-22, under 510(k) number K190539.

Who is the listed applicant for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

The FDA 510(k) record lists Monumedical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile?

The FDA product code for TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile is FMG.

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 CorporationK211204SafePort(TM) Manifold (or Stopcock)Elcam Medical AcalK210516Clicky CrossYomura Technologies, Inc.K190489Elcam 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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