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FDA 510(k)

ENDOLUMINAL ACCESS TUBE

K-Number: K941228 · 1995-09-27

ApplicantMed Institute, Inc.
Decision Date1995-09-27
Product CodeKNT
Advisory CommitteeGU
DecisionUnknown

Device Summary

ENDOLUMINAL ACCESS TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Med Institute, Inc.. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K941228. 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 ENDOLUMINAL ACCESS TUBE?

ENDOLUMINAL ACCESS TUBE is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Med Institute, Inc.. The 510(k) number is K941228.

When did ENDOLUMINAL ACCESS TUBE receive FDA 510(k) clearance?

ENDOLUMINAL ACCESS TUBE received FDA 510(k) clearance on 1995-09-27, under 510(k) number K941228.

Who is the listed applicant for ENDOLUMINAL ACCESS TUBE?

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

What is the FDA product code for ENDOLUMINAL ACCESS TUBE?

The FDA product code for ENDOLUMINAL ACCESS TUBE is KNT.

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Related Devices (Code: KNT)

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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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