← Product Code [KDH](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDH) · K962850 # TUM-E-VAC (K962850) _Ethox Corp. · KDH · Feb 21, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDH/K962850 ## Device Facts - **Applicant:** Ethox Corp. - **Product Code:** [KDH](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDH.md) - **Decision Date:** Feb 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5980 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use The lavage tube is used as a two way conduit from a lavage bag set to the stomach. ## Device Story Disposable, non-sterile dual lumen gastric lavage tube; flexible PVC construction. Device functions as two-way conduit between fluid source/drainage bag and patient stomach. Primary lumen delivers lavage fluid; secondary small-diameter lumen acts as airway vent to prevent vapor lock during fluid aspiration. Used in clinical settings for stomach evacuation; operated by healthcare professionals. Facilitates quicker lavage procedures by enabling continuous fluid flow; allows removal of stomach contents including pill fragments. Benefits patient by reducing procedure time. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Flexible PVC tubing; dual lumen configuration (main fluid conduit and secondary air vent); non-sterile; disposable. ## Regulatory Identification A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use). ## Special Controls *Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K962850 # 510 (k) SUMMARY Ethox Corp. 251 Seneca St. Buffalo NY 14204 716-842-400 716-842-4040 Fax John A Young - Vice President/Operations Dr. J. George Haar - Vice President/Proprietary Sales ## DUAL LUMEN GASTRIC LAVAGE TUBE Comparable to single tube Gastric lavage and stomach evacuator tubes. Disposable, non-sterile tube for gastric lavage. Includes plastic tubing and connectors. The lavage tube is used as a two way conduit from a lavage bag set to the stomach. The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better “back and forth” flow. This is done by allowing air to quickly replace the fluid drawn out during drainage. The dual lumen lavage tube is an improvement to Ethox’s current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any “vapor lock” action. It is a standard accepted feature used in the market. It will not change the function or the lavage procedure in any other way. ![img-0.jpeg](img-0.jpeg) 251 Seneca Street Buffalo, New York 14204-2088 716-842-4000 FAX 716-842-4040 ![img-1.jpeg](img-1.jpeg) --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDH/K962850](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KDH/K962850) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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