Transem and EchoGen Embryo Transfer Catheters— 510(k) K161547
Substantially EquivalentOrigio A/S
FDA 510(k) clearance K161547 for Transem and EchoGen Embryo Transfer Catheters, Substantially Equivalent on 2017-03-09. Applicant: Origio A/S. Device class: 2.
Clearance details
- Applicant
- Origio A/S
- Product code
- Code MQF
- Device class
- Class 2
- Regulation
- 21 CFR 884.6110
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Måløv, DK
Recent devices under product code MQF
view all- K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
- K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500) +4 more
- K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
- K231730 — FemaSeed Intratubal Insemination
- K220010 — Daylily Single Use Sterile Embryo Transfer Catheter
More clearances from Origio A/S
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