Modified Site Disposable Diaphragm Cassette
FDA 510(k) K925921 · Site Microsurgical Systems, Inc.
510(k) numberK925921
Submission
- Device name
- Modified Site Disposable Diaphragm Cassette
- Applicant
- Site Microsurgical Systems, Inc.
Horsham, PA, US - Received
- November 23, 1992
- Decision date
- December 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KYG – Device, Irrigation, Ocular Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4360
- Specialty
- Ophthalmic
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| K003036 | Turbo-Flow Infusion Cannula 19 GAGE,20 GAGE,23 Gage, 25 Gage, Model…KYG · Traditional | Retinalabs.Com | 12/22/2000SE |
| K993591 | Bladeworks Disposable Alk TubingKYG · Traditional | Blade Works, Inc. | 12/28/1999SE |
| K981116 | Sovereign Cataract Extraction SystemKYG · Traditional | Allergan, Inc. | 05/19/1998SE |
| K980647 | Eye Irrigator Model #2020KYG · Traditional | Eye-Deal Ocular Safety Products, Inc. | 05/15/1998SE |
| K974561 | Moistair Fluid Air Tubing SetKYG · Traditional | American Medical Devices, Inc. | 02/19/1998SE |
| K971173 | ML Disposable Alk TubingKYG · Traditional | Med-Logics, Inc. | 05/22/1997SE |
| K970161 | Hedges Corneal Wetting PakKYG · Traditional | Hedges Cwp, Inc. | 03/25/1997SE |
| K954842 | D.O.R.C. Vfi/Vfe SystemKYG · Traditional | Dutch Ophthalmic USA, Inc. | 04/15/1996SE |
| K945171 | Disposable & Resuable Irrigation/Aspiration HandpieceKYG · Traditional | Boston Surgical Products, Inc. | 02/08/1995SE |
More from Boston Surgical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925828 | Modified Site TXR SystemsHQC · Traditional | 02/16/1994SE |
| 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 |
| K904151 | Site 19 Gauge Ultrasonic I/A Phaco NeedleHQC · Traditional | 12/05/1990SE |
Questions and answers
When was Modified Site Disposable Diaphragm Cassette cleared by the FDA?
Modified Site Disposable Diaphragm Cassette (K925921) received a 510(k) decision of Substantially Equivalent on December 6, 1993, 378 days after the submission was received.
What is the product code of K925921?
The FDA product code is KYG – Device, Irrigation, Ocular Surgery, a Class I (low risk) device regulated under 21 CFR 886.4360.