Electrically Controlled I.V. Pole (Opthalmic)
FDA 510(k) K861013 · Ameritek, Inc.
510(k) numberK861013
Submission
- Device name
- Electrically Controlled I.V. Pole (Opthalmic)
- Applicant
- Ameritek, Inc.
Miami, FL, US - Received
- March 18, 1986
- Decision date
- March 31, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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| K990681 | Dbset Multidrug Screen Test KitDKZ · Traditional | 07/15/1999SE |
| K984269 | Dbest Occult Blood Test KitKHE · Traditional | 05/11/1999SE |
| K983191 | Dbest Cocaine Test KitDIO · Traditional | 11/18/1998SE |
| K983190 | Dbest Opiates Test KitDJG · Traditional | 11/18/1998SE |
| K983189 | Dbest Methamphetamines Test KitLAF · Traditional | 11/18/1998SE |
| K983188 | Dbest Tetrahydrocannabinol Test KitLDJ · Traditional | 11/18/1998SE |
| K981504 | Dbest Amphetamines Test KitDKZ · Traditional | 08/06/1998SE |
| K974508 | Dbest One-Step Ovulation TestCEP · Traditional | 02/02/1998SE |
Questions and answers
When was Electrically Controlled I.V. Pole (Opthalmic) cleared by the FDA?
Electrically Controlled I.V. Pole (Opthalmic) (K861013) received a 510(k) decision of Substantially Equivalent on March 31, 1986, 13 days after the submission was received.
What is the product code of K861013?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.