Panpac Disposable Vacuum Curettes
FDA 510(k) K161106 · Panpac Medical Corporation
510(k) numberK161106
Submission
- Device name
- Panpac Disposable Vacuum Curettes
- Applicant
- Panpac Medical Corporation
Shi-Chih Dist., TW - Received
- April 19, 2016
- Decision date
- January 13, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGH – Cannula, Suction, Uterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5070
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172151 | Hysteroscopy SystemHGH · Traditional | Chongquin Jinshan Science & Technology (Group)… | 04/09/2018SE |
| K140213 | Disposable Endoscopic CannulaHGH · Traditional | Dongguan Microview Medical Technology Co., Ltd. | 03/25/2015SE |
| K093508 | Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)HGH · Traditional | Womancare Global | 03/04/2010SE |
| K935820 | Kolster MethodsHGH · Traditional | Kolster Methods | 07/19/1994SE |
| K840285 | Non Stress Test Monitor 507HGH · Traditional | Imex Medical Systems, Inc. | 05/09/1984SE |
More from Imex Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | 10/31/2018SE |
| 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 |
| K092982 | The Panpac Suction CuretteHHK · Traditional | 07/26/2010SE |
| 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 Panpac Disposable Vacuum Curettes cleared by the FDA?
Panpac Disposable Vacuum Curettes (K161106) received a 510(k) decision of Substantially Equivalent on January 13, 2017, 269 days after the submission was received.
What is the product code of K161106?
The FDA product code is HGH – Cannula, Suction, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.5070.