PROINSERT— 510(k) K131145
Substantially EquivalentNidacon International AB
FDA 510(k) clearance K131145 for PROINSERT, Substantially Equivalent on 2014-02-20. Applicant: Nidacon International AB. Device class: 2.
Clearance details
- Applicant
- Nidacon International AB
- Product code
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Naples, FL, US
Recent devices under product code MQK
view all- K241626 — SperSort Sperm Sorting Chip (IPG02)
- K241454 — Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
- K241348 — SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- K241341 — cryo-GO Vitrification Device
- K240002 — G-Vitri Vitrification Straw
More clearances from Nidacon International AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.