Disposable Endoscopic Cannula
FDA 510(k) K140213 · Dongguan Microview Medical Technology Co., Ltd.
510(k) numberK140213
Submission
- Device name
- Disposable Endoscopic Cannula
- Applicant
- Dongguan Microview Medical Technology Co., Ltd.
Shenzhen, Guangdong, CN - Received
- January 28, 2014
- Decision date
- March 25, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K161106 | Panpac Disposable Vacuum CurettesHGH · Traditional | Panpac Medical Corporation | 01/13/2017SE |
| 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 |
Questions and answers
When was Disposable Endoscopic Cannula cleared by the FDA?
Disposable Endoscopic Cannula (K140213) received a 510(k) decision of Substantially Equivalent on March 25, 2015, 421 days after the submission was received.
What is the product code of K140213?
The FDA product code is HGH – Cannula, Suction, Uterine, a Class II (moderate risk) device regulated under 21 CFR 884.5070.