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FDA 510(k)

Gabriel 3 Way EnFit Valve

K-Number: K201741 · 2020-11-05

ApplicantSyncro Medical Innovations, Inc.
Decision Date2020-11-05
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gabriel 3 Way EnFit Valve is the device name listed in this FDA 510(k) record. The listed applicant is Syncro Medical Innovations, Inc.. It received FDA 510(k) clearance on 2020-11-05 under 510(k) number K201741. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gabriel 3 Way EnFit Valve?

Gabriel 3 Way EnFit Valve is a medical device that received FDA 510(k) clearance on 2020-11-05. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K201741.

When did Gabriel 3 Way EnFit Valve receive FDA 510(k) clearance?

Gabriel 3 Way EnFit Valve received FDA 510(k) clearance on 2020-11-05, under 510(k) number K201741.

Who is the listed applicant for Gabriel 3 Way EnFit Valve?

The FDA 510(k) record lists Syncro Medical Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gabriel 3 Way EnFit Valve?

The FDA product code for Gabriel 3 Way EnFit Valve is PIF.

Other records listing Syncro Medical Innovations, Inc. 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.

K191784Gabriel Feeding Tube with Balloon, and EnFit ConnectorK160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with Stylet

Related Devices (Code: PIF)

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.

K254170Percutaneous Endoscopic Gastrostomy (PEG) KitDegania Silicone , Ltd.K242917Enteral Drainage System, Enteral Medicine strawHMC Premedical S.p.A.K250481Extension Feeding Set with ENFit™ ConnectorsSKY Medical, a.s.K240052Disposable Enteral Feeding SetsBeijing L&Z Medical Technology Development Co., Ltd.K233034Mobility+ Enteral Feeding System OTCRockfield MedicalK230326ENFit to ENFit Extension SetsVesco Medical

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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