EMBRYO TRANSFER CATHETERS/SETS— 510(k) K983594
Substantially EquivalentCook Ob/Gyn
FDA 510(k) clearance K983594 for EMBRYO TRANSFER CATHETERS/SETS, Substantially Equivalent on 1998-12-21. Applicant: Cook Ob/Gyn. Device class: 2.
Clearance details
- Applicant
- Cook Ob/Gyn
- 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
- Spencer, IN, US
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 Cook Ob/Gyn
view all- K062438 — BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
- K030441 — SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
- K023850 — SYDNEY IVF EMBRYO BIOPSY MEDIUM
- K013597 — TAMPONADE UTERINE BALLOON CATHETER SET
- K002385 — COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
Recalls naming K983594
K-number listed on FDA's recall record- Z-0415-2020 — Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos into the uterine cavity.
- Z-0416-2020 — Guardia Access Embryo Transfer Catheter is used for transferring IVF embryos into the uterine cavity.
- Z-1188-2018 — 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Number: G19182; 2. Guardia" Access Nano Embryo Transfer Catheter, Catalog Number: K-JETS-551910-L, Global Product Number: G24215; 3. Sydney IVF¿ Embryo Transfer Set, Product Number: K-JETS-7019-SIVF, Global Product Number: G18740
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983594.
Data sourced from openFDA. This site is unofficial and independent of the FDA.