Electric I/V Pole or EIVP2
FDA 510(k) K935003 · Optical Micro Systems, Inc.
510(k) numberK935003
Submission
- Device name
- Electric I/V Pole or EIVP2
- Applicant
- Optical Micro Systems, Inc.
North Andover, MA, US - Received
- October 19, 1993
- Decision date
- January 25, 1994
- 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
Other 510(k)s with product code KYG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010353 | Med-Logics Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 04/27/2001SE |
| K003036 | Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional | Retinalabs.Com | 12/22/2000SE |
| K993591 | Bladeworks Disposable Alk TubingKYG · Traditional | Blade Works, Inc. | 12/28/1999SE |
| K981116 | Sovereign Cataract Extraction SystemKYG · Traditional | Allergan, Inc. | 05/19/1998SE |
| K980647 | Eye Irrigator Model #2020KYG · Traditional | Eye-Deal Ocular Safety Products, Inc. | 05/15/1998SE |
| 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 |
| K954842 | D.O.R.C. Vfi/Vfe SystemKYG · Traditional | Dutch Ophthalmic USA, Inc. | 04/15/1996SE |
| K945171 | Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional | Boston Surgical Products, Inc. | 02/08/1995SE |
More from Boston Surgical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950218 | Oms Slimline Phaco HandpieceHQC · Traditional | 07/17/1995SE |
| K946054 | DiplomaxHQC · Traditional | 07/11/1995SE |
| K935223 | Ophthalmic Surgical SystemHQC · Traditional | 03/14/1994SE |
| K935226 | I/V PoleKYG · Traditional | 02/16/1994SE |
| K870068 | Aspiration Reversal Control (Arc) ModuleHQE · Traditional | 02/12/1987SE |
| K844373 | O.M.S. Ultra-PhacoHQC · Traditional | 12/19/1985SE |
| K844448 | Oms/Gonvers Retinal PerforatorHNM · Traditional | 08/21/1985SE |
| K844895 | Oms Silicone Oil InjectorLWL · Traditional | 06/24/1985SE |
| K844467 | Oms Cryo · Traditional | 02/22/1985SE |
| K844715 | Visc-X Vitreous Aspirating & Cutting Instrument SyHQE · Traditional | 01/22/1985SE |
Questions and answers
When was Electric I/V Pole or EIVP2 cleared by the FDA?
Electric I/V Pole or EIVP2 (K935003) received a 510(k) decision of Substantially Equivalent on January 25, 1994, 98 days after the submission was received.
What is the product code of K935003?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.