D.O.R.C. Vfi/Vfe System
FDA 510(k) K954842 · Dutch Ophthalmic USA, Inc.
510(k) numberK954842
Submission
- Device name
- D.O.R.C. Vfi/Vfe System
- Applicant
- Dutch Ophthalmic USA, Inc.
Kingston, NH, US - Received
- October 23, 1995
- Decision date
- April 15, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KYG – Device, Irrigation, Ocular Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4360
- Specialty
- Ophthalmic
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| K974561 | Moistair Fluid Air Tubing SetKYG · Traditional | American Medical Devices, Inc. | 02/19/1998SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 05/22/1997SE |
| K970161 | Hedges Corneal Wetting PakKYG · Traditional | Hedges Cwp, Inc. | 03/25/1997SE |
| K945171 | Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional | Boston Surgical Products, Inc. | 02/08/1995SE |
| K940392 | Peregrine Pic MinipulatorKYG · Traditional | Peregrine Surgical , Ltd. | 08/23/1994SE |
More from Peregrine Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K012821 | D.O.R.C. Cryostar Cryosurgical SystemHRN · Traditional | 10/22/2001SE |
| K010082 | D.O.R.C. Harmony Total TTC Vitrectomy SystemHQE · Traditional | 03/12/2001SE |
| K983797 | D.O.R.C. Harmony Total Vitrectomy SystemHQE · Traditional | 03/03/1999SE |
| K980636 | Fiber Optic Endoillumination ProbeFFS · Traditional | 05/20/1998SE |
| K973229 | D.O.R.C. Hexon Illumination SystemMPA · Traditional | 11/25/1997SE |
| K973757 | D.O.R.C. Solux Light SourceMPA · Traditional | 11/07/1997SE |
| K962135 | D.O.R.C. Microdiathermy SystemHQO · Traditional | 08/29/1996SE |
| K940373 | Ophthalmic Cryo UnitHPS · Traditional | 07/18/1994SE |
| K902491 | Eckhardt Temporary KeratoprosthesisMLP · Traditional | 06/26/1990SE |
Questions and answers
When was D.O.R.C. Vfi/Vfe System cleared by the FDA?
D.O.R.C. Vfi/Vfe System (K954842) received a 510(k) decision of Substantially Equivalent on April 15, 1996, 175 days after the submission was received.
What is the product code of K954842?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.