Epcom VCU-1 Vacuum System & Curette
FDA 510(k) K831112 · Epcom Medical Systems, Inc.
510(k) numberK831112
Submission
- Device name
- Epcom VCU-1 Vacuum System & Curette
- Applicant
- Epcom Medical Systems, Inc.
Mchenry, IL, US - Received
- April 5, 1983
- Decision date
- June 30, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHI – System, Abortion, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5070
- Specialty
- Obstetrics/Gynecology
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| K983181 | CytoprepHHI · Traditional | Cytoprep Inc. Est. | 11/16/1998SE |
| K931205 | Medi Vac Specimen Collector and TransporterHHI · Traditional | Baxter Healthcare Corp | 03/15/1994SE |
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| K900641 | Cannula, Suction UterineHHI · Traditional | Williams Specialty Products, Inc. | 03/30/1990SE |
| K900642 | Swivel AdapterHHI · Traditional | Williams Specialty Products, Inc. | 03/19/1990SE |
| K880734 | Scented or Scented Deodorized Menstrual PadsHHI · Traditional | Personal Products Co. | 04/25/1988SE |
| K873552 | Cannula and General Purpose AspiratorHHI · Traditional | Cosmedtech, Inc. | 11/25/1987SE |
| K870574 | Cosmedtech General AspiratorHHI · Traditional | Cosmedtech, Inc. | 03/05/1987SE |
More from Cosmedtech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K910518 | Glove-N-Gel Amniotomy KitHGE · Traditional | 05/09/1991SESK |
| K905812 | Intrauterine Catheter SetHGS · Traditional | 01/31/1991SE |
| K881414 | CervicathHDR · Traditional | 06/14/1988SE |
| K871079 | Fetalflex Fetal ElectrodeHGP · Traditional | 07/13/1987SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | 02/25/1985SE |
| K844503 | Urostresstik Diagnostic Cystometry PackFAP · Traditional | 01/02/1985SE |
| K841805 | Obstetrical DopplerKNG · Traditional | 06/19/1984SE |
| K831115 | Epcom EMS-320 Remote MonitorscopeHGM · Traditional | 08/12/1983SE |
| K831114 | Epcom EMS-330 Freedom I Teledop ObstetHGM · Traditional | 08/12/1983SE |
| K831113 | Epcom EMS-310 Intrapartum MonitorHGM · Traditional | 08/12/1983SE |
Questions and answers
When was Epcom VCU-1 Vacuum System & Curette cleared by the FDA?
Epcom VCU-1 Vacuum System & Curette (K831112) received a 510(k) decision of Substantially Equivalent on June 30, 1983, 86 days after the submission was received.
What is the product code of K831112?
The FDA product code is HHI – System, Abortion, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 884.5070.