FDA 510(k)

FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT

K-Number: K885339 · 1989-03-01

ApplicantSuperior Healthcare Group, Inc.

Decision Date1989-03-01

Product CodeKNT

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

FLOW THRU 16,18,20,22 FR REPLACE. GASTRO 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 1989-03-01 under 510(k) number K885339. 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 FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT?

FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT is a medical device that received FDA 510(k) clearance on 1989-03-01. The listed applicant is Superior Healthcare Group, Inc.. The 510(k) number is K885339.

When did FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT receive FDA 510(k) clearance?

FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT received FDA 510(k) clearance on 1989-03-01, under 510(k) number K885339.

Who is the listed applicant for FLOW THRU 16,18,20,22 FR REPLACE. GASTRO 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 FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT?

The FDA product code for FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT is KNT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 14 devices →

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.