Product code HHI
- Device name
- System, Abortion, Vacuum
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5070
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171440 | Berkeley VC-10 Vacuum Curettage System | Gyrus Acmi | 2017-09-29 |
| K030935 | BERKELEY V-10 VACUUM CURETTAGE SYSTEM | Acmi Corporation | 2003-06-23 |
| K983181 | CYTOPREP | Cytoprep Inc. Est. | 1998-11-16 |
| K931205 | MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER | Baxter Healthcare Corp | 1994-03-15 |
| K904160 | CYTOSMEAR BRUSH | Brooke Intl. | 1990-11-02 |
| K900641 | CANNULA, SUCTION UTERINE | Williams Specialty Products, Inc. | 1990-03-30 |
| K900642 | SWIVEL ADAPTER | Williams Specialty Products, Inc. | 1990-03-19 |
| K880734 | SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS | Personal Products Co. | 1988-04-25 |
| K873552 | CANNULA AND GENERAL PURPOSE ASPIRATOR | Cosmedtech, Inc. | 1987-11-25 |
| K870574 | COSMEDTECH GENERAL ASPIRATOR | Cosmedtech, Inc. | 1987-03-05 |
| K870560 | COSMEDTECH CANNULA | Cosmedtech, Inc. | 1987-03-04 |
| K862476 | LS3000 CANNULA UTERINE SUCTION | Engineering, Inc. | 1986-07-18 |
| K850312 | GYNASPYR VACUUM CURETTAGE UNIT | Roseburg SA | 1985-02-28 |
| K841631 | MODEL 3014 SUCTION UNIT | Forma Scientific, Inc. | 1984-07-03 |
| K840381 | TAPERED CERVICAL DILATOR | Intl. Medical Technologies, Inc. | 1984-04-30 |
| K840382 | VACUUM ASPIRATION CATHETER | Intl. Medical Technologies, Inc. | 1984-04-30 |
| K840383 | MENSTRUAL ASPIRATION KIT | Intl. Medical Technologies, Inc. | 1984-04-30 |
| K840384 | DIAGNOSTIC DILATATION & MENSTRUAL KIT | Intl. Medical Technologies, Inc. | 1984-04-30 |
| K840952 | MEDEVICE V-80 VACUUM PUMP | Berkeley Medevices | 1984-03-30 |
| K831112 | EPCOM VCU-1 VACUUM SYSTEM & CURETTE | Epcom Medical Systems, Inc. | 1983-06-30 |
| K813282 | SYNEVAC VACUUM CURETTAGE SYSTEMS | Synemed, Inc. | 1981-12-14 |
| K802360 | UTERINE VACUM ASPIRATING CURRETTE | American Hospital Supply Corp. | 1980-10-31 |
| K800833 | VABRA ASPIRATOR | Cooper Medical Devices Corp. | 1980-05-14 |
| K780387 | VABRA ABORTION UNIT | Cooper Laboratories | 1978-04-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| GYNX31351 | Gynex | GYNEX CORPORATION | 2023-12-26 |
| GYNX31300 | Gynex | GYNEX CORPORATION | 2023-12-26 |
| GYNX31350 | Gynex | GYNEX CORPORATION | 2023-12-26 |
| GYNX31301 | Gynex | GYNEX CORPORATION | 2023-12-26 |
| 04055207040027 | NA | Richard Wolf GmbH | 2022-10-27 |
| M803022734 | MedGyn Pipette II | MEDGYN PRODUCTS, INC. | 2020-12-14 |
| M803022730 | MedGyn Pipette IV | MEDGYN PRODUCTS, INC. | 2020-12-14 |
| M803022721 | MedGyn Pipette | MEDGYN PRODUCTS, INC. | 2020-12-14 |
| 00821925030862 | Gyrus ACMI | Gyrus ACMI, LLC | 2017-05-10 |
| 00821925009561 | GYRUS ACMI | Gyrus ACMI, LLC | 2017-05-09 |
| 00821925010475 | BERKELEY | Gyrus ACMI, LLC | 2016-10-18 |
| 00821925008632 | Berkeley 1/2" Collection Set | Gyrus Acmi, Inc. | 2016-10-13 |
| 00821925000971 | VACURETTE STRAIGHT 10MM 10PKG | Gyrus Acmi, Inc. | 2016-10-11 |
| 00821925000964 | VACURETTE STRAIGHT 9MM 10/PKG | Gyrus Acmi, Inc. | 2016-10-11 |
| 00821925000940 | 21163 Permeable Gauze Sacks (10/Pkg) | Gyrus Acmi, Inc. | 2016-10-11 |
| 00821925000919 | VACURETTE CURVED 8MM 10/PKG | Gyrus Acmi, Inc. | 2016-10-11 |
| 00821925004184 | Collection Set, Disposable with Handle and Tapered Fitting Tubing 6 f | Gyrus Acmi, Inc. | 2016-10-11 |
| 04055207040003 | NA | Richard Wolf GmbH | 2016-09-26 |
| 04055207040010 | NA | Richard Wolf GmbH | 2016-09-26 |
| 00853615006314 | WomanCare Global Ipas MVA Plus® Aspirator Accessory Kit | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006321 | WomanCare Global Single-Valve Aspirator Accessory Kit | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006352 | WomanCare Global Single-Valve Aspirator | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006369 | WomanCare Global Double-Valve Aspirator | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006307 | WomanCare Global Uterine Evacuation Kit | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006291 | WomanCare Global Miscarriage Management Kit | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006277 | WomanCare Global Single-Valve Aspirator | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006253 | WomanCare Global Double-Valve Aspirator | WOMANCARE GLOBAL TRADING, INC. | 2016-09-17 |
| 00853615006260 | WomanCare Global Ipas MVA Plus Aspirator | WOMANCARE GLOBAL TRADING, INC. | 2016-09-07 |
| M803022312 | MedGyn collection set | MEDGYN PRODUCTS, INC. | 2016-09-07 |
| M803022310 | medgyn collection set | MEDGYN PRODUCTS, INC. | 2016-09-07 |