Grieshaber Viscoelastic Injection System
FDA 510(k) K890783 · Grieshaber & Co.
510(k) numberK890783
Submission
- Device name
- Grieshaber Viscoelastic Injection System
- Applicant
- Grieshaber & Co.
Langhorne, PA, US - Received
- February 15, 1989
- Decision date
- May 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
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| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 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 |
| K914587 | Grieshaber Air/Fluid Tubing SetKYG · Traditional | 01/23/1992SE |
| 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 |
| K884043 | Grieshaber Micro Lite Light Pipe 19 & 20 GaugeHQE · Traditional | 11/16/1988SE |
Questions and answers
When was Grieshaber Viscoelastic Injection System cleared by the FDA?
Grieshaber Viscoelastic Injection System (K890783) received a 510(k) decision of Substantially Equivalent on May 16, 1989, 90 days after the submission was received.
What is the product code of K890783?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.