# Cook Ob/Gyn

- Location (FDA's records): Spencer, IN
- FDA decisions: 43 (1985–2006): 43 510(k) clearances
- Product codes: MQF (5), HET (5), MQL (4), HDR (3), HFE (2), MFD (2), MQG (2), KNA (2), GCJ (2), MOV (1), EZN (1), HAM (1)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 43 (1 its own)
- Recalls linked to its devices: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Cook, Inc.: 8 (https://510kreport.com/company/cook)
- William A. Cook Australia Pty., Ltd.: 7 (https://510kreport.com/company/william-a-cook-australia)
- Rocket Medical Plc: 3 (https://510kreport.com/company/rocket-medical)
- Portex, Inc.: 2 (https://510kreport.com/company/portex)
- Utah Medical Products, Inc.: 2 (https://510kreport.com/company/utah-medical-products)
- Cook Urological, Inc.: 2 (https://510kreport.com/company/cook-urological)
- Medworks Corp.: 2 (https://510kreport.com/company/medworks)
- Glenveigh Surgical, LLC: 2 (https://510kreport.com/company/glenveigh-surgical)

## Its most-cited devices
- K983594: Embryo Transfer Catheters/Sets (1998), cited by 6
- K983593: Ovum Pick-UP Aspiration Needles (1999), cited by 5
- K013597: Tamponade Uterine Balloon Catheter Set (2002), cited by 4
- K914150: Jansen-Anderson Insemination Set (1992), cited by 3
- K002385: Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium, (2000), cited by 3
- K062438: Bakri Postpartum Balloon, Model J-Sos-100500 (2006), cited by 3

## Recent decisions
- K062438: Bakri Postpartum Balloon, Model J-Sos-100500 (Oct 27, 2006)
- K030441: Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw Kit (Aug 29, 2003)
- K023850: Sydney Ivf Embryo Biopsy Medium (Jan 22, 2003)
- K013597: Tamponade Uterine Balloon Catheter Set (Apr 17, 2002)
- K002385: Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization Medium, Cook Ivf Cleavage Medium, (Sep 18, 2000)
- K002383: Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit (Sep 13, 2000)
- K983595: Transmyometrial Embryo Transfer Set (Feb 8, 1999)
- K983596: Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, Assisted Hatching (Feb 5, 1999)

Source page: https://510kreport.com/company/cook-ob-gyn