Apple Medical One-Touch Uterine Sampler
FDA 510(k) K000026 · Apple Medical Corp.
510(k) numberK000026
Submission
- Device name
- Apple Medical One-Touch Uterine Sampler
- Applicant
- Apple Medical Corp.
Marlboro, MA, US - Received
- January 5, 2000
- Decision date
- March 31, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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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|---|---|---|
| K061651 | Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158HGI · Traditional | 10/20/2006SE |
| K050256 | Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional | 04/26/2005SE |
| K041131 | Apple Medical Ob Mobius Elastic RetractorGCJ · Traditional | 05/13/2004SE |
| K014005 | Apple Medical Mobius Elastic RetractorGCJ · Traditional | 02/15/2002SE |
| K970788 | Pneumo-Matic Insufflation NeedleFHO · Traditional | 03/27/1997SE |
| K961460 | Lweet Cone Biopsy InstrumentHGI · Traditional | 11/19/1996SE |
| K952841 | The AssistantFHA · Traditional | 08/18/1995SE |
| K941506 | Ureteral IlluminatorFCS · Traditional | 10/05/1994SE |
Questions and answers
When was Apple Medical One-Touch Uterine Sampler cleared by the FDA?
Apple Medical One-Touch Uterine Sampler (K000026) received a 510(k) decision of Substantially Equivalent on March 31, 2000, 86 days after the submission was received.
What is the product code of K000026?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.