Cannula, Suction, Uterine
The Uterine Suction Cannula is a thin, hollow tube used in vacuum aspiration procedures to evacuate the uterine cavity contents, employed in procedures such as surgical abortion, management of miscarriage, or endometrial sampling. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HGH, regulated under 21 CFR 884.5070, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
Basic Information
- Product Code
- HGH
- Device Class
- FDA class 2
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172151 | Hysteroscopy System | Apr 09, 2018 | Substantially Equivalent | Chongquin Jinshan Science & Technology (Group) Co., Ltd. |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Jan 13, 2017 | Substantially Equivalent | PANPAC MEDICAL CORPORATION |
| K140213 | DISPOSABLE ENDOSCOPIC CANNULA | Mar 25, 2015 | Substantially Equivalent | DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD |
| K093508 | RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) | Mar 04, 2010 | Substantially Equivalent | WOMANCARE GLOBAL |
| K935820 | KOLSTER METHODS | Jul 19, 1994 | Substantially Equivalent | KOLSTER METHODS |
| K840285 | NON STRESS TEST MONITOR 507 | May 09, 1984 | Substantially Equivalent | IMEX MEDICAL SYSTEMS, INC. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.