FGD · Catheter, Retention, Barium Enema With Bag
Gastroenterology, Urology · 21 CFR 876.5980 · Class 2
Overview
| Product Code | FGD |
|---|---|
| Device Name | Catheter, Retention, Barium Enema With Bag |
| Regulation | 21 CFR 876.5980 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223890 | NAJA Gastrointestinal Catheter | Chess Medical, Inc. | Jun 16, 2023 | SESE |
| K905026 | DUAL FLEX NON-LATEX | Mmi, Inc. | Dec 18, 1991 | SESE |
| K905574 | SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFF | E-Z-Em, Inc. | Jan 24, 1991 | SESE |
| K904299 | SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF | E-Z-Em, Inc. | Nov 27, 1990 | SESE |
| K884379 | MAGLINTE ENTEROCLYSIS CATHETER | Lafayette Pharmacal, Inc. | Feb 28, 1989 | SESE |
| K872006 | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF | Mac Lee Medical Products | Nov 17, 1987 | SESE |
Top Applicants
- E-Z-Em, Inc. — 2 clearances
- Chess Medical, Inc. — 1 clearance
- Lafayette Pharmacal, Inc. — 1 clearance
- Mac Lee Medical Products — 1 clearance
- Mmi, Inc. — 1 clearance
