KDH · Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | KDH |
|---|---|
| Device Name | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
(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.
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.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K983624 | GILTECH PLUS CONNECTING TUBE SET | Giltech Plus, Inc. | Mar 18, 1999 | SESE |
| K981286 | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | Armm, Inc. | Jun 19, 1998 | SESE |
| K971259 | COMBIPORT FLUID LAVAGE DEVICE | B.Braun Medical, Inc. | Oct 27, 1997 | SESE |
| K962850 | TUM-E-VAC | Ethox Corp. | Feb 21, 1997 | SESE |
| K951533 | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | Ballard Medical Products | Jul 5, 1995 | SESE |
| K923497 | FLUSHING IRRIGATION SET | Orion Life Systems, Inc. | Mar 21, 1994 | SESK |
| K920619 | TRI-MED GASTRIC LAVAGE SYSTEM | Tri-Med Specialties, Inc. | Sep 4, 1992 | SESE |
| K920527 | TRI-MED QUICK-STEP GASTRIC LAVAGE KIT | Tri-Med Specialties, Inc. | Sep 4, 1992 | SESE |
| K914908 | QUICVAGE PLUS | Autovage | Apr 13, 1992 | SESK |
| K914907 | QUICVAGE | Autovage | Jan 24, 1992 | SESE |
| K911919 | MINIVAGE(R) | Autovage | Jul 26, 1991 | SESE |
| K911788 | ECONOVAGE R | Autovage | Jul 26, 1991 | SESE |
| K911324 | IRRIGATION/ASPIRATION TUBING SET | Biomedical Dynamics, Inc. | Jun 24, 1991 | SESE |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Gainor Medical Europe, Ltd. | Nov 20, 1990 | SESE |
| K900086 | HEMORRHOIDAL LIGATOR WITH SUCTION | Baxter Healthcare Corp | Mar 19, 1990 | SESE |
| K896573 | EASI-LAV ADULT GASTRIC LAVAGE KIT | Clairson Industries, LLC | Jan 29, 1990 | SESE |
| K892334 | LEONARD TUBE | Surgidyne, Inc. | May 31, 1989 | SESE |
| K860599 | ETHOX LAVAGE TUBE | Ethox Corp. | Mar 11, 1986 | SESE |
| K821496 | DISPOSABLE IRRIGA/ASPIR. SYSTEM | Innovative Surgical Products, Inc. | Jun 22, 1982 | SESE |
| K781749 | TUBING, AXIOM SILICONE PENROSE | Axiom Medical, Inc. | Dec 4, 1978 | SESE |
Top Applicants
- Autovage — 4 clearances
- Ethox Corp. — 2 clearances
- Sherwood Medical Industries — 2 clearances
- Tri-Med Specialties, Inc. — 2 clearances
- Armm, Inc. — 1 clearance
