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FDA 510(k)

MRI'S ALL SILICONE GASTROSTOMY TUBE

K-Number: K951489 · 1995-06-07

ApplicantManufacturing & Research, Inc.
Decision Date1995-06-07
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MRI'S ALL SILICONE GASTROSTOMY TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Manufacturing & Research, Inc.. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K951489. 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 MRI'S ALL SILICONE GASTROSTOMY TUBE?

MRI'S ALL SILICONE GASTROSTOMY TUBE is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Manufacturing & Research, Inc.. The 510(k) number is K951489.

When did MRI'S ALL SILICONE GASTROSTOMY TUBE receive FDA 510(k) clearance?

MRI'S ALL SILICONE GASTROSTOMY TUBE received FDA 510(k) clearance on 1995-06-07, under 510(k) number K951489.

Who is the listed applicant for MRI'S ALL SILICONE GASTROSTOMY TUBE?

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

What is the FDA product code for MRI'S ALL SILICONE GASTROSTOMY TUBE?

The FDA product code for MRI'S ALL SILICONE GASTROSTOMY TUBE is KNT.

Related Clinical Trials

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Other records listing Manufacturing & Research, 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.

K083684ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX

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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