EYN · Tray, Irrigation, Sterile
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | EYN |
|---|---|
| Device Name | Tray, Irrigation, Sterile |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K944882 | IRRIGATION TRAY | Clinical Resources, Inc. | Jan 12, 1995 | SESE |
| K923941 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE | American Healthcare Corp. | Jun 17, 1993 | SEKD |
| K923940 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE | American Healthcare Corp. | Jun 17, 1993 | SEKD |
| K923939 | IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER | American Healthcare Corp. | Jun 17, 1993 | SEKD |
| K923938 | IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER | American Healthcare Corp. | Jun 17, 1993 | SEKD |
| K900148 | KIT PAK IRRIGATION TRAY | Kit Pak, Inc. | Apr 23, 1990 | SEKD |
| K900737 | PISTON IRRIGATION TRAY | Orion Life Systems, Inc. | Apr 19, 1990 | SESK |
| K900736 | BULB IRRIGATION TRAY | Orion Life Systems, Inc. | Apr 17, 1990 | SESK |
| K801783 | CATHETER IRRIGATION TRAYS, #3300, 3310 & | The Healthcare Group Laboratories, Inc. | Aug 13, 1980 | SESE |
| K792082 | GAVAGE FEEDING SET | Medical Devices, Inc. | Nov 13, 1979 | SESE |
| K791020 | FLUID ADMINISTRATION SET FA-3160 | Burron Medical Products, Inc. | Jun 27, 1979 | SESE |
| K790607 | GREENLINE IRRIGATION TRAYS | Snyder Laboratories, Inc. | May 11, 1979 | SESE |
| K781918 | IRRIGATOR, BODY CAVITY | Bci, Inc. | Feb 15, 1979 | SESE |
| K781748 | IRRIGATION TRAY | Intermed, Inc. | Dec 12, 1978 | SESE |
| K760047 | TRAY, BLADDER IRRIGATION | M-C Ind., Inc. | Mar 1, 1977 | SESE |
Top Applicants
- American Healthcare Corp. — 4 clearances
- Orion Life Systems, Inc. — 2 clearances
- Bci, Inc. — 1 clearance
- Burron Medical Products, Inc. — 1 clearance
- Clinical Resources, Inc. — 1 clearance
