Bag, Stomal
The Bag, Stomal (product code GDS) is an external collection device worn over a surgical stoma, such as a colostomy or ileostomy, to collect waste output from the bowel or urinary system redirected through the abdominal wall after gastrointestinal or urological surgery. It is classified as FDA Class 1, posing minimal risk, subject only to general controls and not requiring premarket notification. The device is regulated under 21 CFR 876.5900 in the Gastroenterology, Urology specialty (GU). No special flags apply to this device.
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Basic Information
- Product Code
- GDS
- Device Class
- FDA class 1
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.