Site 20 Gauge Reusable Fiber Optic Cable
FDA 510(k) K910980 · Site Microsurgical Systems, Inc.
510(k) numberK910980
Submission
- Device name
- Site 20 Gauge Reusable Fiber Optic Cable
- Applicant
- Site Microsurgical Systems, Inc.
Horsham, PA, US - Received
- March 7, 1991
- Decision date
- May 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
Other 510(k)s with product code HJO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253834 | Visuref 600HJO · Traditional | Carl Zeiss Vision GmbH | 03/18/2026SE |
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | Cylite Pty. , Ltd. | 03/08/2024SE |
| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 01/14/2020SE |
| K182306 | Sunkingdom Slit LampHJO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 11/22/2018SE |
| K173771 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 08/24/2018SE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
More from Carl Zeiss Meditec, AG
| 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 |
| K905620 | Modified Site Peristaltic FootswitchEBW · Traditional | 02/27/1991SE |
| K904183 | Site Phacoemulsification HandpieceHQC · Traditional | 12/05/1990SE |
| K904151 | Site 19 Gauge Ultrasonic I/A Phaco NeedleHQC · Traditional | 12/05/1990SE |
Questions and answers
When was Site 20 Gauge Reusable Fiber Optic Cable cleared by the FDA?
Site 20 Gauge Reusable Fiber Optic Cable (K910980) received a 510(k) decision of Substantially Equivalent on May 22, 1991, 76 days after the submission was received.
What is the product code of K910980?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.