Curelle, Preferred Curelle, Cuteq 2.5
FDA 510(k) K020628 · Bioteque America, Inc.
510(k) numberK020628
Submission
- Device name
- Curelle, Preferred Curelle, Cuteq 2.5
- Applicant
- Bioteque America, Inc.
Langhorne, PA, US - Received
- February 26, 2002
- Decision date
- May 24, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
| K201952 | CrossGlide ETS PlusHHK · Special | Crossbay Medical | 08/05/2020SE |
| 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 |
| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26HHK · Traditional | Sims Portex , Ltd. | 08/02/2000SE |
More from Sims Portex , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K041094 | HSG Catheter SetLKF · Traditional | 06/17/2004SE |
| K013289 | Bioteque Vaginal PessariesHHW · Traditional | 12/27/2001SE |
| K003380 | Bioteque Vaginal DilatorHDX · Traditional | 01/29/2001SE |
| K920633 | Pessary Flexible Silicone NicholsKXP · Traditional | 11/08/1995SE |
| K920747 | Pessary Flexible Silicone Donut RingHHW · Traditional | 08/29/1994SE |
| K933628 | Cytology BrushHHT · Traditional | 03/11/1994SE |
| K933521 | SpeculumHIB · Traditional | 03/07/1994SE |
| K920187 | Flexible Silicone GelihornHHW · Traditional | 10/23/1992SE |
| K920177 | Versa-VialDQF · Traditional | 07/13/1992SE |
Questions and answers
When was Curelle, Preferred Curelle, Cuteq 2.5 cleared by the FDA?
Curelle, Preferred Curelle, Cuteq 2.5 (K020628) received a 510(k) decision of Substantially Equivalent on May 24, 2002, 87 days after the submission was received.
What is the product code of K020628?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.