HGH · Cannula, Suction, Uterine
Obstetrics/Gynecology · 21 CFR 884.5070 · Class 2
Overview
| Product Code | HGH |
|---|---|
| Device Name | Cannula, Suction, Uterine |
| Regulation | 21 CFR 884.5070 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
A vacuum abortion system is a device designed to aspirate transcervically the products of conception or menstruation from the uterus by using a cannula connected to a suction source. This device is used for pregnancy termination or menstrual regulation. This type of device may include aspiration cannula, vacuum source, and vacuum controller.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | Apr 9, 2018 | SESE |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Panpac Medical Corporation | Jan 13, 2017 | SESE |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Dongguan Microview Medical Technology Co., Ltd. | Mar 25, 2015 | SESE |
| K093508 | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) | Womancare Global | Mar 4, 2010 | SESE |
| K935820 | KOLSTER METHODS | Kolster Methods | Jul 19, 1994 | SESE |
| K840285 | NON STRESS TEST MONITOR 507 | Imex Medical Systems, Inc. | May 9, 1984 | SESE |
Top Applicants
- Chongquin Jinshan Science & Technology (Group) Co., Ltd. — 1 clearance
- Dongguan Microview Medical Technology Co., Ltd. — 1 clearance
- Imex Medical Systems, Inc. — 1 clearance
- Kolster Methods — 1 clearance
- Panpac Medical Corporation — 1 clearance
