Med-Logics Disposable Alk Tubing
FDA 510(k) K010353 · Med-Logics, Inc.
510(k) numberK010353
Submission
- Device name
- Med-Logics Disposable Alk Tubing
- Applicant
- Med-Logics, Inc.
Laguna Niguel,, CA, US - Received
- February 6, 2001
- Decision date
- April 27, 2001
- 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 |
|---|---|---|---|
| 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 |
| K940392 | Peregrine Pic MinipulatorKYG · Traditional | Peregrine Surgical , Ltd. | 08/23/1994SE |
More from Peregrine Surgical , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K033293 | Med-Logics, Model ML7090HNO · Traditional | 01/13/2004SE |
| K022982 | Med-Logics Microkeratome Blade, Model 7050CLBHNO · Traditional | 11/15/2002SE |
| K022716 | Med-Logics Microkeratome Blade, Model 7020CLBHNO · Traditional | 10/11/2002SE |
| K010872 | ML Blade, Model ML7030HNO · Traditional | 06/22/2001SE |
| K002515 | Medlogics ML 4000, Model 4000HNO · Traditional | 02/22/2001SE |
| K002279 | ML Eye Spear, Model ML 27 EsHOZ · Traditional | 08/18/2000SE |
| K983448 | ML Universal TubingMSR · Traditional | 12/18/1998SE |
| K981071 | ML MicrokeratomeHNO · Traditional | 07/23/1998SE |
| K972522 | Ml-Disposable PakMSR · Traditional | 09/30/1997SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | 05/22/1997SE |
Questions and answers
When was Med-Logics Disposable Alk Tubing cleared by the FDA?
Med-Logics Disposable Alk Tubing (K010353) received a 510(k) decision of Substantially Equivalent on April 27, 2001, 80 days after the submission was received.
What is the product code of K010353?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.