Gi Bleeder/Od Set
510(k) K913476
Gi Bleeder/Od Set is a medical device (FDA Class II; FDA product code KNT, Tubes, Gastrointestinal (And Accessories)) made by ICU Medical, Inc., cleared under FDA 510(k) K913476 on 12 Feb 1992, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESK | NumberK913476 | Date12 Feb 1992 | StatusActive |
Official records
- FDA 510(k) database K913476
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNT
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESK Substantially Equivalent — Kit
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