.2MM, .4MM, .5MM Irrigation and Aspiration Hand.
FDA 510(k) K883926 · Site Microsurgical Systems, Inc.
510(k) numberK883926
Submission
- Device name
- .2MM, .4MM, .5MM Irrigation and Aspiration Hand.
- Applicant
- Site Microsurgical Systems, Inc.
Horsham, PA, US - Received
- September 15, 1988
- Decision date
- November 15, 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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| K921135 | Iolab Power I.V. PoleHQC · Traditional | 06/03/1992SE |
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| K912902 | Phacoemulsification System for Ophthalmic UseHQC · Traditional | 12/17/1991SE |
| K912739 | Site 90 Tip, I/A Handpiece .3MM Side Open/Opth UseHQC · Traditional | 08/28/1991SE |
| K910980 | Site 20 Gauge Reusable Fiber Optic CableHJO · Traditional | 05/22/1991SE |
| K905620 | Modified Site Peristaltic FootswitchEBW · Traditional | 02/27/1991SE |
| K904183 | Site Phacoemulsification HandpieceHQC · Traditional | 12/05/1990SE |
Questions and answers
When was .2MM, .4MM, .5MM Irrigation and Aspiration Hand. cleared by the FDA?
.2MM, .4MM, .5MM Irrigation and Aspiration Hand. (K883926) received a 510(k) decision of Substantially Equivalent on November 15, 1988, 61 days after the submission was received.
What is the product code of K883926?
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.