FDA 510(k) Applications Submitted by Naomi Funkhouser
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180300 |
02/02/2018 |
Margolin HSG Cannula, Goldstein Sonohysterography Catheter |
Cook Incorporated |
| K180302 |
02/02/2018 |
GuardiaÖ Access Malleable Obturator, GuardiaÖ Obturator, Soft-PassÖ Obturator, Soft-Trans Malleable Obturator, GuardiaÖ ETS Embryo-Tested Syringe, Flushing Catheter |
Cook Incorporated |
| K170622 |
03/01/2017 |
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component |
Cook Incorporated |
| K180552 |
03/01/2018 |
Modified Novy Cornual Cannulation Set |
Cook Incorporated |
| K150748 |
03/23/2015 |
Flexipet Denuding Pipette, Flexipet Manipulation Pipette |
COOK INCORPORATED |
| K151018 |
04/16/2015 |
Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette |
COOK INCORPORATED |
| K172051 |
07/06/2017 |
GuardiaÖ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter |
Cook Incorporated |
| K172321 |
08/01/2017 |
Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters |
Cook Incorporated |
| K173103 |
09/29/2017 |
Pivet and Soft-Pass Embryo Transfer Catheter Sets |
Cook Incorporated |
| K173686 |
12/01/2017 |
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF« Transfer Catheter |
Cook Incorporated |
| K163318 |
11/23/2016 |
Soules Intrauterine Insemination Catheter |
Cook Incorporated |
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