Kitazato OPU Needles— 510(k) K162881
Substantially EquivalentKitazato Corporation
FDA 510(k) clearance K162881 for Kitazato OPU Needles, Substantially Equivalent on 2017-07-11. Applicant: Kitazato Corporation. Device class: 2.
Clearance details
- Applicant
- Kitazato Corporation
- Product code
- Code MQE
- Device class
- Class 2
- Regulation
- 21 CFR 884.6100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code MQE
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- K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)
- K191291 — Wallace Dual Lumen Oocyte Recovery System
More clearances from Kitazato Corporation
view all- K260248 — Ultra-Fast Warm
- K251305 — Ultra-Fast Vitri; Ultra-Fast Warm
- K200249 — Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA])
- K193522 — iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
- K192845 — Sperm Freeze, Sperm Fridge
Data sourced from openFDA. This site is unofficial and independent of the FDA.