CPR D & C Tray
FDA 510(k) K960239 · Custom Pack Reliability
510(k) numberK960239
Submission
- Device name
- CPR D & C Tray
- Applicant
- Custom Pack Reliability
Orlando, FL, US - Received
- January 16, 1996
- Decision date
- May 23, 1996
- 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 |
More from Bioteque America, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960205 | CPR Tracheotomy Care TrayBTO · Traditional | 08/27/1996SE |
| K960243 | CPR C-Section Delivery PackMLS · Traditional | 05/23/1996SE |
| K960216 | CPR Suction Catheter KitJOL · Traditional | 04/15/1996SE |
| K960213 | CPR Total Hip PackFRG · Traditional | 04/12/1996SE |
| K960211 | CPR Total Knee PackFRG · Traditional | 04/12/1996SE |
| K960210 | CPR Ortho Hand PackFRG · Traditional | 04/12/1996SE |
| K960206 | CPR Dressing Change TrayFRG · Traditional | 04/12/1996SE |
| K960209 | CPR Heart PackGAW · Traditional | 04/04/1996SE |
| K960215 | CPR Urethral Catheter TrayFCM · Traditional | 04/01/1996SE |
| K960214 | CPR Foley Cahteter KitFCM · Traditional | 04/01/1996SE |
Questions and answers
When was CPR D & C Tray cleared by the FDA?
CPR D & C Tray (K960239) received a 510(k) decision of Substantially Equivalent on May 23, 1996, 128 days after the submission was received.
What is the product code of K960239?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.