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FDA 510(k)

ENConnect 40 mm Screw Cap to ENPlus Adapter

K-Number: K190327 · 2019-04-09

ApplicantCedic S.R.L.
Decision Date2019-04-09
Product CodePIF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENConnect 40 mm Screw Cap to ENPlus Adapter is the device name listed in this FDA 510(k) record. The listed applicant is Cedic S.R.L.. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K190327. 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 ENConnect 40 mm Screw Cap to ENPlus Adapter?

ENConnect 40 mm Screw Cap to ENPlus Adapter is a medical device that received FDA 510(k) clearance on 2019-04-09. The listed applicant is Cedic S.R.L.. The 510(k) number is K190327.

When did ENConnect 40 mm Screw Cap to ENPlus Adapter receive FDA 510(k) clearance?

ENConnect 40 mm Screw Cap to ENPlus Adapter received FDA 510(k) clearance on 2019-04-09, under 510(k) number K190327.

Who is the listed applicant for ENConnect 40 mm Screw Cap to ENPlus Adapter?

The FDA 510(k) record lists Cedic S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENConnect 40 mm Screw Cap to ENPlus Adapter?

The FDA product code for ENConnect 40 mm Screw Cap to ENPlus Adapter is PIF.

Other records listing Cedic S.R.L. 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.

K181787Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesK162254Cedic Enteral ENFit Transition Connectors

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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