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FDA 510(k)

MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE

K-Number: K021991 · 2002-07-18

ApplicantSyncro Medical Innovations, Inc.
Decision Date2002-07-18
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE 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 2002-07-18 under 510(k) number K021991. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE?

MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE is a medical device that received FDA 510(k) clearance on 2002-07-18. The listed applicant is Syncro Medical Innovations, Inc.. The 510(k) number is K021991.

When did MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE receive FDA 510(k) clearance?

MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE received FDA 510(k) clearance on 2002-07-18, under 510(k) number K021991.

Who is the listed applicant for MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE?

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 MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE?

The FDA product code for MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE is KNT.

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Other records listing Syncro Medical Innovations, Inc. as applicant

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K201741Gabriel 3 Way EnFit ValveK191784Gabriel Feeding Tube with Balloon, and EnFit ConnectorK160787Gabriel Feeding Tube with Balloon, Magnetically Guided Feeding Tube w/Balloon, Gabriel Feeding Tube with Balloon, Preassembled with StyletK110005SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBEK072787GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111

Related Devices (Code: KNT)

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.

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLCK253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300)C.R. Bard, Inc.K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,LtdK243228Flexi-Seal AIR (with ENFit Connector)ConvatecK242336hygh-tec Drainage IIAmb MedtecK242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)Tools For Surgery, LLC

Official Source

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