Grieshaber Air/Fluid Tubing Set
FDA 510(k) K914587 · Grieshaber & Co.
510(k) numberK914587
Submission
- Device name
- Grieshaber Air/Fluid Tubing Set
- Applicant
- Grieshaber & Co.
Langhorne, PA, US - Received
- October 16, 1991
- Decision date
- January 23, 1992
- 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 |
|---|---|---|
| K950056 | The Grieshaber Axial CutterHKP · Traditional | 05/05/1995SE |
| K930842 | The Grieshaber Syst/Ai Tubing Set and CartridgeHQE · Traditional | 05/03/1994SE |
| K914588 | Grieshaber Snare Instrument and Snare CartridgeGAW · Traditional | 06/11/1992SE |
| K914586 | Grieshaber Three Function ManipulatorEQH · Traditional | 01/03/1992SE |
| K914585 | Grieshaber Two Function ManipulatorEQH · Traditional | 01/03/1992SE |
| K897119 | Grieshaber Retinal Tack and Sutherland Tack ForcepHQW · Traditional | 04/12/1990SE |
| K900714 | Zzipp Instant Bovie CleanerGEI · Traditional | 03/27/1990SE |
| K890782 | Grieshaber Soft Tip Needle (20 & 19 Gauges)HMX · Traditional | 06/23/1989SE |
| K890783 | Grieshaber Viscoelastic Injection SystemFRN · Traditional | 05/16/1989SE |
| K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 GaugeHQE · Traditional | 11/16/1988SE |
Questions and answers
When was Grieshaber Air/Fluid Tubing Set cleared by the FDA?
Grieshaber Air/Fluid Tubing Set (K914587) received a 510(k) decision of Substantially Equivalent on January 23, 1992, 99 days after the submission was received.
What is the product code of K914587?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.