PLI
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Gastrointestional Tube Holder
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- Intended to support, secure, and hold gastrointestinal tubes
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| DALE GASTROSTOMY TUBE HOLDER (K961693) | Dale Medical Products, Inc. | 1996-07-30 |
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Every clearance here is in the API, with alerts when new ones post.