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FDA 510(k)

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE

K-Number: K990863 · 1999-04-06

ApplicantRoss Product Div. Abbott Laboratories
Decision Date1999-04-06
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Ross Product Div. Abbott Laboratories. It received FDA 510(k) clearance on 1999-04-06 under 510(k) number K990863. 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 MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE?

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1999-04-06. The listed applicant is Ross Product Div. Abbott Laboratories. The 510(k) number is K990863.

When did MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE receive FDA 510(k) clearance?

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE received FDA 510(k) clearance on 1999-04-06, under 510(k) number K990863.

Who is the listed applicant for MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE?

The FDA 510(k) record lists Ross Product Div. Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE?

The FDA product code for MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE is KNT.

Related Clinical Trials

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Other records listing Ross Product Div. Abbott Laboratories 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.

K031407ROSS EMBRACE ENTERAL PUMPK003047AMBULATORY ENTERAL NUTRITION PUMPK992494FLEXIFLO ENTERAL 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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