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FDA 510(k)

MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT

K-Number: K852363 · 1985-08-09

ApplicantMedical Innovations Corp.
Decision Date1985-08-09
Product CodeKNT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Innovations Corp.. It received FDA 510(k) clearance on 1985-08-09 under 510(k) number K852363. 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 MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT?

MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT is a medical device that received FDA 510(k) clearance on 1985-08-09. The listed applicant is Medical Innovations Corp.. The 510(k) number is K852363.

When did MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT receive FDA 510(k) clearance?

MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT received FDA 510(k) clearance on 1985-08-09, under 510(k) number K852363.

Who is the listed applicant for MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT?

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

What is the FDA product code for MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT?

The FDA product code for MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT is KNT.

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Other records listing Medical Innovations Corp. 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.

K945612MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBEK940548MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBEK943685MIC DISPOSABLE SNAREK926581MIC TRANSGASTRIC JEJUNAL TUBEK921370MIC GASTRO-ENTEROSTOMY TUBE MODIFICATIONK921652MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT

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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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