Grieshaber Soft Tip Needle (20 & 19 Gauges)
FDA 510(k) K890782 · Grieshaber & Co.
510(k) numberK890782
Submission
- Device name
- Grieshaber Soft Tip Needle (20 & 19 Gauges)
- Applicant
- Grieshaber & Co.
Langhorne, PA, US - Received
- February 15, 1989
- Decision date
- June 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMX – Cannula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HMX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010305 | Weiss Retinal CannulaHMX · Traditional | Micron Surgical, Inc. | 05/02/2001SE |
| K000457 | Vertefusion-Photodynamic Therapy Pak, Model 11000 Series; Photofusion-Photodynamic…HMX · Traditional | Retinalabs.Com | 05/09/2000SE |
| K970873 | Endosoft Soft Tip Needle (20 Ga. and 19 Ga.)HMX · Traditional | American Medical Devices, Inc. | 05/20/1997SE |
| K943932 | Steriseal Ophthalmic CannulaHMX · Traditional | Pharma-Plast, Ltd. | 01/18/1995SE |
| K942403 | Infusion CannulaHMX · Traditional | Microsurgical Technology, Inc. | 08/17/1994SE |
| K934844 | Inter Tip THMX · Traditional | Microsurgical Technology, Inc. | 04/19/1994SE |
| K930113 | Kirwan Irrigation/Aspiration HandpieceHMX · Traditional | Kirwan Surgical Products, Inc. | 02/17/1994SE |
| K921488 | Aspirating Endo Ocular Probe W/IlluminationHMX · Traditional | Surgical Technologies, Inc. | 05/07/1992SE |
| K915074 | Irrigator/Aspirator ProbeHMX · Traditional | Biomedical Dynamics, Inc. | 02/05/1992SE |
| K904074 | Vitreoretinal Infusion CannulaHMX · Traditional | Visitec Co. | 02/26/1991SE |
More from Visitec Co.
| 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 |
| 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 Soft Tip Needle (20 & 19 Gauges) cleared by the FDA?
Grieshaber Soft Tip Needle (20 & 19 Gauges) (K890782) received a 510(k) decision of Substantially Equivalent on June 23, 1989, 128 days after the submission was received.
What is the product code of K890782?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.