Sepragel Sinus
510(k) K012532
Sepragel Sinus is a Class I device made by Genzyme Corp., cleared under FDA 510(k) K012532 on 30 Oct 2001, 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)SESE | NumberK012532 | Date30 Oct 2001 | StatusActive |
Official records
- FDA 510(k) database K012532
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LYA
- Device class
- Class I
- Regulation
- 21 CFR Part 874.4780
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
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