CrossGlide ETS Plus
FDA 510(k) K201952 · Crossbay Medical
510(k) numberK201952
Submission
- Device name
- CrossGlide ETS Plus
- Applicant
- Crossbay Medical
San Diego, CA, US - Received
- July 14, 2020
- Decision date
- August 5, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HHK – Curette, Suction, Endometrial (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1175
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251882 | Uterine Aspiration SetHHK · Traditional | Gcmedica Enterprise Ltd.(Wuxi) | 10/16/2025SE |
| K240434 | RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)HHK · Traditional | Li Medical Corporation , Ltd. | 09/25/2024SE |
| K192534 | CrossBay Endometrial Tissue Sampler (ETS)HHK · Traditional | Crossbay Medical | 03/25/2020SE |
| K102847 | Disposable Endometrial Suction CuretteHHK · Traditional | Jiangsu Suyun Medical Materials Co., Ltd. | 04/14/2011SE |
| K092982 | The Panpac Suction CuretteHHK · Traditional | Panpac Medical Corporation | 07/26/2010SE |
| K051294 | Femtest Endometrial Suction Curette, Model FT-1HHK · Traditional | Femspec LLC | 12/21/2005SE |
| K040189 | Endometrial Sampling SyringeHHK · Traditional | Rocket Medical Plc | 10/04/2004SE |
| K021876 | Mas with or Without SyringeHHK · Traditional | Marina Medical Instruments, Inc. | 04/08/2003SE |
| K020628 | Curelle, Preferred Curelle, Cuteq 2.5HHK · Traditional | Bioteque America, Inc. | 05/24/2002SE |
| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26HHK · Traditional | Sims Portex , Ltd. | 08/02/2000SE |
More from Sims Portex , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K192534 | CrossBay Endometrial Tissue Sampler (ETS)HHK · Traditional | 03/25/2020SE |
| K190813 | CrossBay Cervical Dilator Catheter SystemPON · Traditional | 08/23/2019SE |
| K162064 | CrossBay IVF Embryo Transfer Catheter SetMQF · Traditional | 01/05/2017SE |
| K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography DeviceLKF · Traditional | 03/20/2015SE |
| K133144 | Sonosure Sonohysterography & Endometrial Sampling DevicePGK · Traditional | 03/19/2014SE |
Questions and answers
When was CrossGlide ETS Plus cleared by the FDA?
CrossGlide ETS Plus (K201952) received a 510(k) decision of Substantially Equivalent on August 5, 2020, 22 days after the submission was received.
What is the product code of K201952?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.