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FDA 510(k)

FLEXIFLO GASTROSTOMY KIT

K-Number: K932861 · 1994-06-09

ApplicantAbbott Laboratories
Decision Date1994-06-09
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

FLEXIFLO GASTROSTOMY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1994-06-09 under 510(k) number K932861. 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 FLEXIFLO GASTROSTOMY KIT?

FLEXIFLO GASTROSTOMY KIT is a medical device that received FDA 510(k) clearance on 1994-06-09. The listed applicant is Abbott Laboratories. The 510(k) number is K932861.

When did FLEXIFLO GASTROSTOMY KIT receive FDA 510(k) clearance?

FLEXIFLO GASTROSTOMY KIT received FDA 510(k) clearance on 1994-06-09, under 510(k) number K932861.

Who is the listed applicant for FLEXIFLO GASTROSTOMY KIT?

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 GASTROSTOMY KIT?

The FDA product code for FLEXIFLO GASTROSTOMY KIT 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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