Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES

K-Number: K100700 · 2010-12-13

ApplicantBenlan, Inc.
Decision Date2010-12-13
Product CodeFPD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Benlan, Inc.. It received FDA 510(k) clearance on 2010-12-13 under 510(k) number K100700. 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 MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES?

MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2010-12-13. The listed applicant is Benlan, Inc.. The 510(k) number is K100700.

When did MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES receive FDA 510(k) clearance?

MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES received FDA 510(k) clearance on 2010-12-13, under 510(k) number K100700.

Who is the listed applicant for MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES?

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

What is the FDA product code for MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES?

The FDA product code for MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Benlan, 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.

K120375MED-RX PATIENT DELIVERY SETK112799MED-RX EXTENSION SET WITH T-CONNECTORK102073MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TSK010607MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001K990777MED-RX EXTENSION SETS

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.

↑