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FDA 510(k)

ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE

K-Number: K901134 · 1990-06-20

ApplicantFresenius Pharma
Decision Date1990-06-20
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Pharma. It received FDA 510(k) clearance on 1990-06-20 under 510(k) number K901134. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE?

ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1990-06-20. The listed applicant is Fresenius Pharma. The 510(k) number is K901134.

When did ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE receive FDA 510(k) clearance?

ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE received FDA 510(k) clearance on 1990-06-20, under 510(k) number K901134.

Who is the listed applicant for ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE?

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

What is the FDA product code for ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE?

The FDA product code for ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE is KNT.

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 Fresenius Pharma 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.

K914216FRENTA II+ ENTERAL FEEDING PUMPK901130ENTERA-FLO FEEDING TUBE

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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