Flyte
by Pelvital USA, Inc. 2 variants
510(k) K210764
Flyte is a Class II device made by Pelvital USA, Inc., cleared under FDA 510(k) K210764 on 13 Apr 2021, 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 | NumberK210764 | Date13 Apr 2021 | StatusActive |
Official records
- FDA 510(k) database K210764
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HIR
- Device class
- Class II
- Regulation
- 21 CFR Part 884.1425
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
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