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FDA 510(k)

AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE

K-Number: K100526 · 2010-04-22

ApplicantKentec Medical, Inc.
Decision Date2010-04-22
Product CodeFPD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Kentec Medical, Inc.. It received FDA 510(k) clearance on 2010-04-22 under 510(k) number K100526. The device is classified under product code FPD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE?

AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Kentec Medical, Inc.. The 510(k) number is K100526.

When did AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE receive FDA 510(k) clearance?

AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE received FDA 510(k) clearance on 2010-04-22, under 510(k) number K100526.

Who is the listed applicant for AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE?

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

What is the FDA product code for AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE?

The FDA product code for AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE is FPD.

Related Clinical Trials

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.

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Other records listing Kentec Medical, 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.

K120272AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SETK050443ACCU-LEADK970686ACCUTEMP-PROBEK960080ACCUTEMP PROBEK853475GRAM-MA NEONATAL SC

Related Devices (Code: FPD)

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.

K243361NutrifitVygon USAK180236VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)Vr Medical Technology Co., Ltd.K131590INNERSENSE ESOPHAGEAL TEMPERATURE PROBE / FEEDING TUBEPhilips Medical SystemsK120815INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBEPhilips Medical SystemsK121105NUTRISAFE 2 FEEDING TUBEVygon Corp.K100163NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXXVygon Corp.

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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