The Panpac Suction Curette
FDA 510(k) K092982 · Panpac Medical Corporation
510(k) numberK092982
Submission
- Device name
- The Panpac Suction Curette
- Applicant
- Panpac Medical Corporation
Shi-Chih City, Taipei Hsien, TW - Received
- September 28, 2009
- Decision date
- July 26, 2010
- 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 |
| 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 |
| K001555 | Suresample-Wallace Endometrial Sampler, Endo 26HHK · Traditional | Sims Portex , Ltd. | 08/02/2000SE |
More from Sims Portex , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | 10/31/2018SE |
| K161106 | Panpac Disposable Vacuum CurettesHGH · Traditional | 01/13/2017SE |
| K153422 | Panpac Disposable Pessary Fitting SetHHW · Special | 07/14/2016SE |
| K132670 | Panpac Inflatable Docut PessaryHHW · Traditional | 06/04/2014SE |
| K130087 | Panpac Word/Bartholin CatheterKNA · Traditional | 01/10/2014SE |
| K130273 | Panpac Vaginal DilatorsHDX · Traditional | 08/08/2013SE |
| K102898 | Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography…LKF · Traditional | 12/15/2011SE |
| K092981 | Panpac Vaginal PessaryHHW · Traditional | 07/22/2010SE |
| K092983 | Panpac HSG Catheter SetLKF · Traditional | 06/07/2010SE |
| K092984 | Panpac Uterine Inector, Model UI-4.0, UI-2.0LKF · Traditional | 04/07/2010SE |
Questions and answers
When was The Panpac Suction Curette cleared by the FDA?
The Panpac Suction Curette (K092982) received a 510(k) decision of Substantially Equivalent on July 26, 2010, 301 days after the submission was received.
What is the product code of K092982?
The FDA product code is HHK – Curette, Suction, Endometrial (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1175.