Disp. 20 Gauge Site Fiber Optic Cable & Illumi.
FDA 510(k) K883975 · Site Microsurgical Systems, Inc.
510(k) numberK883975
Submission
- Device name
- Disp. 20 Gauge Site Fiber Optic Cable & Illumi.
- Applicant
- Site Microsurgical Systems, Inc.
Horsham, PA, US - Received
- September 20, 1988
- Decision date
- October 25, 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
Other 510(k)s with product code HQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212763 | UniVit HE, UniVit UHSHQE · Traditional | Visioncare Devices, LLC | 08/10/2022SE |
| K170183 | Cetus system, Cetus probeHQE · Traditional | A.R.C Laser GmbH | 09/27/2017SE |
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | Medical Instrument Development Laboratories | 04/29/2016SE |
| K141065 | Constellation Vision SystemHQE · Traditional | Alcon Research, Ltd. | 08/22/2014SE |
| K121675 | VersavitHQE · Traditional | Synergetics, Inc. | 06/21/2012SE |
| K120170 | Procare Plus Vitrectomy SystemHQE · Traditional | Visioncare Devices, Inc. | 05/30/2012SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | Medical Instrument Development Laboratories, Inc. | 04/08/2011SE |
| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
More from Visioncare Devices, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925828 | Modified Site TXR SystemsHQC · Traditional | 02/16/1994SE |
| K925921 | Modified Site Disposable Diaphragm CassetteKYG · Traditional | 12/06/1993SE |
| K931866 | Site's CD II Phacoemulsification HandpieceHQC · Traditional | 11/12/1993SE |
| K921135 | Iolab Power I.V. PoleHQC · Traditional | 06/03/1992SE |
| K920582 | 180 Tip, 1/A Handpiece .3MM End Opening for Opht.HQE · Traditional | 05/08/1992SE |
| 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 Disp. 20 Gauge Site Fiber Optic Cable & Illumi. cleared by the FDA?
Disp. 20 Gauge Site Fiber Optic Cable & Illumi. (K883975) received a 510(k) decision of Substantially Equivalent on October 25, 1988, 35 days after the submission was received.
What is the product code of K883975?
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.