Endometrial Pipelle
FDA 510(k) K854415 · Unimar, Inc.
510(k) numberK854415
Submission
- Device name
- Endometrial Pipelle
- Applicant
- Unimar, Inc.
Wilton, CT, US - Received
- November 4, 1985
- Decision date
- March 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K020628 | Curelle, Preferred Curelle, Cuteq 2.5HHK · Traditional | Bioteque America, Inc. | 05/24/2002SE |
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| K932432 | Kronner Reinforcing StyletteLKF · Traditional | 04/12/1994SE |
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| K910317 | Uni-Sem(Tm)MFD · Traditional | 05/01/1991SE |
| K904473 | Kronner ManipujectorHES · Traditional | 12/14/1990SE |
| K895659 | Hui Mini-FlexHIG · Traditional | 12/19/1989SE |
| K895403 | Aspirette Endocervical AspiratorHFC · Traditional | 11/29/1989SE |
| K894264 | KDF-2.3HDR · Traditional | 08/15/1989SE |
| K890848 | Cervex-BrushHHT · Traditional | 05/11/1989SE |
| K810291 | Sterile/Disposable HSG TrayEYY · Traditional | 03/18/1981SE |
Questions and answers
When was Endometrial Pipelle cleared by the FDA?
Endometrial Pipelle (K854415) received a 510(k) decision of Substantially Equivalent on March 13, 1986, 129 days after the submission was received.
What is the product code of K854415?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.