FDA 510(k)

88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT

K-Number: K853353 · 1985-11-04

ApplicantSuperior Healthcare Group, Inc.

Decision Date1985-11-04

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Superior Healthcare Group, Inc.. It received FDA 510(k) clearance on 1985-11-04 under 510(k) number K853353. 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 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT?

88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT is a medical device that received FDA 510(k) clearance on 1985-11-04. The listed applicant is Superior Healthcare Group, Inc.. The 510(k) number is K853353.

When did 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT receive FDA 510(k) clearance?

88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT received FDA 510(k) clearance on 1985-11-04, under 510(k) number K853353.

Who is the listed applicant for 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT?

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

What is the FDA product code for 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT?

The FDA product code for 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT is KNT.

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Other records listing Superior Healthcare Group, Inc. as applicant

K925530INSTRUMENT WARMER K924764OVERTUBE FOR ENDSCOPIC LIGATOR K905755NON-STERILE PATIENT EXAMINATION GLOVES K903347SODIUM CHLORIDE SOLUTION K904216STERILE WATER SOLUTION CATALOG # 10000 K903340STERILE URETHRAL CATHETER PROCEDURE KITS

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Related Devices (Code: KNT)

K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC K253514Minnesota 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.,Ltd K243228Flexi-Seal AIR (with ENFit Connector)Convatec K242336hygh-tec Drainage IIAmb Medtec K242901ZZIREN™ 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.