Stovall Endometrial Brush
FDA 510(k) K911620 · Cook Ob/Gyn
510(k) numberK911620
Submission
- Device name
- Stovall Endometrial Brush
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- April 11, 1991
- Decision date
- June 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFE – Brush, Endometrial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1100
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240595 | Utepreva Endometrial Sampler (UP01)HFE · Traditional | Utepreva, LLC | 08/14/2024SE |
| K170603 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | Cook Incorporated | 05/24/2017SE |
| K112763 | Matrixbrush Endometrial SamplerHFE · Traditional | Post Oak Innovations, Inc. | 06/18/2012SE |
| K082066 | Tao Brush I.U.M.C. Endometrial SamplerHFE · Traditional | Cook Urological, Inc. | 11/07/2008SE |
| K941298 | Iumc Endometrial SamplerHFE · Traditional | Cook Ob/Gyn | 02/13/1995SE |
| K897070 | Endobrush(Tm) Device; OmnibrushHFE · Traditional | Intl. Cytobrush, Inc. | 09/10/1990SE |
| K881220 | Endocyte, Disposable Endometrial SamplerHFE · Traditional | Laboratoire Ccd C/O Washington Regulatory Services | 06/14/1988SE |
| K843941 | EndocyteHFE · Traditional | Gyneco, Inc. | 02/25/1985SE |
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| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | 01/22/2003SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | 04/17/2002SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | 09/13/2000SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | 02/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | 02/05/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | 02/01/1999SE |
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Questions and answers
When was Stovall Endometrial Brush cleared by the FDA?
Stovall Endometrial Brush (K911620) received a 510(k) decision of Substantially Equivalent on June 24, 1994, 1,170 days after the submission was received.
What is the product code of K911620?
The FDA product code is HFE – Brush, Endometrial, a Class II (moderate risk) device regulated under 21 CFR 884.1100.