KYG · Device, Irrigation, Ocular Surgery
Ophthalmic · 21 CFR 886.4360 · Class 1
Overview
| Product Code | KYG |
|---|---|
| Device Name | Device, Irrigation, Ocular Surgery |
| Regulation | 21 CFR 886.4360 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 40)
Showing 20 most recent of 40 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010353 | MED-LOGICS DISPOSABLE ALK TUBING | Med-Logics, Inc. | Apr 27, 2001 | SESE |
| K003036 | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 | Retinalabs.Com | Dec 22, 2000 | SESE |
| K993591 | BLADEWORKS DISPOSABLE ALK TUBING | Blade Works, Inc. | Dec 28, 1999 | SESE |
| K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM | Allergan, Inc. | May 19, 1998 | SESE |
| K980647 | EYE IRRIGATOR MODEL #2020 | Eye-Deal Ocular Safety Products, Inc. | May 15, 1998 | SESE |
| K974561 | MOISTAIR FLUID AIR TUBING SET | American Medical Devices, Inc. | Feb 19, 1998 | SESE |
| K971173 | ML DISPOSABLE ALK TUBING | Med-Logics, Inc. | May 22, 1997 | SESE |
| K970161 | HEDGES CORNEAL WETTING PAK | Hedges Cwp, Inc. | Mar 25, 1997 | SESE |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | Dutch Ophthalmic USA, Inc. | Apr 15, 1996 | SESE |
| K945171 | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE | Boston Surgical Products, Inc. | Feb 8, 1995 | SESE |
| K940392 | PEREGRINE PIC MINIPULATOR | Peregrine Surgical , Ltd. | Aug 23, 1994 | SESE |
| K935226 | I/V POLE | Optical Micro Systems, Inc. | Feb 16, 1994 | SESE |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | Optical Micro Systems, Inc. | Jan 25, 1994 | SESE |
| K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | Dec 6, 1993 | SESE |
| K924999 | AUTOPOLE REGULATOR SYSTEM | Escalon Trek Medical | Dec 24, 1992 | SESE |
| K924052 | INFINITY MICRO IRRIGATOR | Infinity Surgical Technology, Inc. | Dec 23, 1992 | SESE |
| K922996 | MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS | Chiron Vision Corp. | Jul 27, 1992 | SESE |
| K922180 | LEWICKY O.R.S. TUBING | O.R. Specialties, Inc. | Jul 2, 1992 | SESE |
| K915808 | AQUEOUS PARACENTESIS PIPET | Visitec Co. | Mar 19, 1992 | SESE |
| K914587 | GRIESHABER AIR/FLUID TUBING SET | Grieshaber & Co. | Jan 23, 1992 | SESE |
Top Applicants
- Visitec Co. — 3 clearances
- Surgeon Surgical Instrumentation, Inc. — 2 clearances
- Site Microsurgical Systems, Inc. — 2 clearances
- Optical Micro Systems, Inc. — 2 clearances
- Mortan, Inc. — 2 clearances
