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FDA 510(k)

BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES

K-Number: K983476 · 1999-03-01

ApplicantNavion Biomedical Corp.
Decision Date1999-03-01
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Navion Biomedical Corp.. It received FDA 510(k) clearance on 1999-03-01 under 510(k) number K983476. 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 BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES?

BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES is a medical device that received FDA 510(k) clearance on 1999-03-01. The listed applicant is Navion Biomedical Corp.. The 510(k) number is K983476.

When did BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES receive FDA 510(k) clearance?

BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES received FDA 510(k) clearance on 1999-03-01, under 510(k) number K983476.

Who is the listed applicant for BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES?

The FDA 510(k) record lists Navion Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES?

The FDA product code for BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES is KNT.

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Other records listing Navion Biomedical Corp. 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.

K9730571.4 FR MAPCATH SENSOR STYLETK952626MAPWIRE J-TIP SENSOR GUIDEWIREK940385NAVIGATOR-MP CATHETER LOCATION INSTRUMENTK901263NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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