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FDA 510(k)

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

K-Number: K020985 · 2002-06-25

ApplicantTfx Medical, Inc.
Decision Date2002-06-25
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER is the device name listed in this FDA 510(k) record. The listed applicant is Tfx Medical, Inc.. It received FDA 510(k) clearance on 2002-06-25 under 510(k) number K020985. 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 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER?

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER is a medical device that received FDA 510(k) clearance on 2002-06-25. The listed applicant is Tfx Medical, Inc.. The 510(k) number is K020985.

When did MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER receive FDA 510(k) clearance?

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER received FDA 510(k) clearance on 2002-06-25, under 510(k) number K020985.

Who is the listed applicant for MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER?

The FDA 510(k) record lists Tfx Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER?

The FDA product code for MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER is KNT.

Related Clinical Trials

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Other records listing Tfx Medical, Inc. 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.

K021034MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCERK000665TFX MEDICAL SAFETY NEEDLE WITH INTRODUCERK993191TFX MEDICAL INTRODUCER ASSEMBLY

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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