Multi-Spike
FDA 510(k) K861203 · Surgeon Surgical Instrumentation, Inc.
510(k) numberK861203
Submission
- Device name
- Multi-Spike
- Applicant
- Surgeon Surgical Instrumentation, Inc.
Anaheim, CA, US - Received
- April 1, 1986
- Decision date
- April 28, 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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|---|---|---|---|
| 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 |
|---|---|---|
| K954241 | Surgin Genisis PhacoemulsifierHQC · Traditional | 12/01/1995SE |
| K932281 | Verres NeedleGCT · Traditional | 08/06/1993SE |
| K922038 | CO2 Insufflation TubingHIF · Traditional | 10/13/1992SE |
| K904010 | Surgical Aspirator KitLFL · Traditional | 11/21/1990SE |
| K890447 | Hemorrhage OccludorGDW · Traditional | 02/23/1989SE |
| K880543 | Uni-PortKYG · Traditional | 07/01/1988SE |
| K881232 | Surgin Eye ShieldHOY · Traditional | 04/13/1988SE |
| K852229 | Sterile Eye Packs or Trays · Traditional | 06/07/1985SE |
| K830859 | I/A KitGBX · Traditional | 05/02/1983SE |
Questions and answers
When was Multi-Spike cleared by the FDA?
Multi-Spike (K861203) received a 510(k) decision of Substantially Equivalent on April 28, 1986, 27 days after the submission was received.
What is the product code of K861203?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.