Curelle
FDA 510(k) K915491 · Bioteque Corp.
510(k) numberK915491
Submission
- Device name
- Curelle
- Applicant
- Bioteque Corp.
Levittown, PA, US - Received
- December 6, 1991
- Decision date
- November 4, 1992
- 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
Other 510(k)s with product code HHK
| 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 |
| 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 |
| K020628 | Curelle, Preferred Curelle, Cuteq 2.5HHK · Traditional | Bioteque America, Inc. | 05/24/2002SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | 12/22/2025SE |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-seriesFGE · Traditional | 04/13/2022SE |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type)FGE · Traditional | 10/09/2020SE |
| K150932 | Sheath IntroducerDRE · Traditional | 07/22/2016SE |
| K102633 | Bioteq Angiographic CatheterDQO · Traditional | 09/09/2011SE |
| K033862 | Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String LockFGE · Traditional | 02/14/2005SE |
| K033210 | Bioteq Double Pigtail Ureteral Stent SetFAD · Traditional | 12/30/2004SE |
| K032292 | Bioteque A.V. Fistula Needle Set with Safety FlexFOZ · Traditional | 03/22/2004SE |
| K013634 | Bioteque 3 in 1 Hemodialysis Blood Tubing PackFJK · Traditional | 07/09/2002SESK |
| K012526 | Bioteque Scalp Vein SetFPA · Traditional | 09/14/2001SE |
Questions and answers
When was Curelle cleared by the FDA?
Curelle (K915491) received a 510(k) decision of Substantially Equivalent on November 4, 1992, 334 days after the submission was received.
What is the product code of K915491?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.