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FDA 510(k)

SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)

K-Number: K041034 · 2004-08-31

ApplicantEntracare, LLC
Decision Date2004-08-31
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) is the device name listed in this FDA 510(k) record. The listed applicant is Entracare, LLC. It received FDA 510(k) clearance on 2004-08-31 under 510(k) number K041034. 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 SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)?

SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) is a medical device that received FDA 510(k) clearance on 2004-08-31. The listed applicant is Entracare, LLC. The 510(k) number is K041034.

When did SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) receive FDA 510(k) clearance?

SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) received FDA 510(k) clearance on 2004-08-31, under 510(k) number K041034.

Who is the listed applicant for SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)?

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

What is the FDA product code for SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)?

The FDA product code for SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL) is KNT.

Related Clinical Trials

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Other records listing Entracare, LLC 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.

K092418ENTRACARE GASTROSTOMY FEEDING TUBEK053429ADVANCED UROLOGICAL CATHETER

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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