Acu-Evac
FDA 510(k) K930043 · Acuderm, Inc.
510(k) numberK930043
Submission
- Device name
- Acu-Evac
- Applicant
- Acuderm, Inc.
Ft. Lauderdale, FL, US - Received
- January 5, 1993
- Decision date
- February 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FYD – Apparatus, Exhaust, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5070
- Specialty
- General, Plastic Surgery
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More from I.C Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933516 | Acu-E PunchLRY · Traditional | 03/24/1994SE |
| K933265 | Acu-Dispo-Ce(Tm)MDM · Traditional | 03/07/1994SE |
| K933137 | Acu-Suture KitLRO · Traditional | 02/22/1994SE |
| K933866 | Acu-Hemostatic RingMDM · Traditional | 12/01/1993SE |
| K915000 | Acu-GuardGEX · Traditional | 01/27/1992SE |
| K891334 | Acu-CuretteFZS · Traditional | 04/11/1989SE |
| K874024 | Acu-Micro-NeedleFMI · Traditional | 11/23/1987SE |
| K854877 | Acu-Syringe W/Wo NeedlesFMF · Traditional | 02/19/1986SE |
| K832583 | Sabouraud Dextrose AgarJSJ · Traditional | 09/12/1983SE |
| K832582 | Mycosel AgarJSJ · Traditional | 09/12/1983SE |
Questions and answers
When was Acu-Evac cleared by the FDA?
Acu-Evac (K930043) received a 510(k) decision of Substantially Equivalent on February 9, 1994, 400 days after the submission was received.
What is the product code of K930043?
The FDA product code is FYD – Apparatus, Exhaust, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.5070.