Grieshaber Micro Lite Light Pipe 19 & 20 Gauge
FDA 510(k) K884043 · Grieshaber & Co.
510(k) numberK884043
Submission
- Device name
- Grieshaber Micro Lite Light Pipe 19 & 20 Gauge
- Applicant
- Grieshaber & Co.
Langhorne, PA, US - Received
- September 26, 1988
- Decision date
- November 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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More from Visioncare Devices, 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 |
| 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 |
| K890783 | Grieshaber Viscoelastic Injection SystemFRN · Traditional | 05/16/1989SE |
Questions and answers
When was Grieshaber Micro Lite Light Pipe 19 & 20 Gauge cleared by the FDA?
Grieshaber Micro Lite Light Pipe 19 & 20 Gauge (K884043) received a 510(k) decision of Substantially Equivalent on November 16, 1988, 51 days after the submission was received.
What is the product code of K884043?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.