Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter

Catheter, Assisted Reproduction

Cook Incorporated

The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-pass™ Obturator, Soft-trans Malleable Obturator, Guardia™ Ets Embryo-tested Syringe, Flushing Catheter.

Pre-market Notification Details

• Device ID: K180302
• 510k Number: K180302
• Device Name: Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
• Classification: Catheter, Assisted Reproduction
• Applicant: Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
• Contact: Naomi Funkhouser
• Correspondent: Naomi Funkhouser; Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
• Product Code: MQF
• CFR Regulation Number: 884.6110 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-02-02
• Decision Date: 2018-10-24
• Summary: summary