Proinsert
510(k) K131145
Proinsert is a medical device (FDA Class II; FDA product code MQK, Labware, Assisted Reproduction) made by Nidacon International Ab, cleared under FDA 510(k) K131145 on 20 Feb 2014, 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 | NumberK131145 | Date20 Feb 2014 | StatusActive |
Official records
- FDA 510(k) database K131145
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQK
- Device class
- Class II
- Regulation
- 21 CFR Part 884.6160
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
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