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FDA 510(k)

FLEXIFLO POLYG GASTOSTOMY TUBE

K-Number: K963113 · 1996-10-02

ApplicantAbbott Laboratories
Decision Date1996-10-02
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIFLO POLYG GASTOSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1996-10-02 under 510(k) number K963113. 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 FLEXIFLO POLYG GASTOSTOMY TUBE?

FLEXIFLO POLYG GASTOSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1996-10-02. The listed applicant is Abbott Laboratories. The 510(k) number is K963113.

When did FLEXIFLO POLYG GASTOSTOMY TUBE receive FDA 510(k) clearance?

FLEXIFLO POLYG GASTOSTOMY TUBE received FDA 510(k) clearance on 1996-10-02, under 510(k) number K963113.

Who is the listed applicant for FLEXIFLO POLYG GASTOSTOMY TUBE?

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

What is the FDA product code for FLEXIFLO POLYG GASTOSTOMY TUBE?

The FDA product code for FLEXIFLO POLYG GASTOSTOMY TUBE is KNT.

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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

View on FDA Database →

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

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