FDA Product Code
FDA Product Code KYG — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4360
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K010353 | MED-LOGICS DISPOSABLE ALK TUBING | Med-Logics, Inc. | 2001-04-27 | Traditional | PDF ↗ |
| K003036 | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 | Retinalabs.Com | 2000-12-22 | Traditional | PDF ↗ |
| K993591 | BLADEWORKS DISPOSABLE ALK TUBING | Blade Works, Inc. | 1999-12-28 | Traditional | PDF ↗ |
| K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM | Allergan, Inc. | 1998-05-19 | Traditional | PDF ↗ |
| K980647 | EYE IRRIGATOR MODEL #2020 | Eye-Deal Ocular Safety Products, Inc. | 1998-05-15 | Traditional | PDF ↗ |
| K974561 | MOISTAIR FLUID AIR TUBING SET | American Medical Devices, Inc. | 1998-02-19 | Traditional | PDF ↗ |
| K971173 | ML DISPOSABLE ALK TUBING | Med-Logics, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K970161 | HEDGES CORNEAL WETTING PAK | Hedges Cwp, Inc. | 1997-03-25 | Traditional | PDF ↗ |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | Dutch Ophthalmic USA, Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K945171 | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE | Boston Surgical Products, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K940392 | PEREGRINE PIC MINIPULATOR | Peregrine Surgical , Ltd. | 1994-08-23 | Traditional | PDF ↗ |
| K935226 | I/V POLE | Optical Micro Systems, Inc. | 1994-02-16 | Traditional | PDF ↗ |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | Optical Micro Systems, Inc. | 1994-01-25 | Traditional | PDF ↗ |
| K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | 1993-12-06 | Traditional | PDF ↗ |
| K924999 | AUTOPOLE REGULATOR SYSTEM | Escalon Trek Medical | 1992-12-24 | Traditional | PDF ↗ |
| K924052 | INFINITY MICRO IRRIGATOR | Infinity Surgical Technology, Inc. | 1992-12-23 | Traditional | PDF ↗ |
| K922996 | MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS | Chiron Vision Corp. | 1992-07-27 | Traditional | PDF ↗ |
| K922180 | LEWICKY O.R.S. TUBING | O.R. Specialties, Inc. | 1992-07-02 | Traditional | PDF ↗ |
| K915808 | AQUEOUS PARACENTESIS PIPET | Visitec Co. | 1992-03-19 | Traditional | PDF ↗ |
| K914587 | GRIESHABER AIR/FLUID TUBING SET | Grieshaber & Co. | 1992-01-23 | Traditional | PDF ↗ |
| K904186 | SITE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | 1990-11-21 | Traditional | PDF ↗ |
| K881518 | INFUSION HANDLE | B&B Medical Assoc., Inc. | 1988-08-22 | Traditional | PDF ↗ |
| K881517 | B & B I/A HANDPIECE | B&B Medical Assoc., Inc. | 1988-08-22 | Traditional | PDF ↗ |
| K881682 | ALCON SITE(R)-COMPATIBLE CASSETTE | Alcon Laboratories | 1988-07-01 | Traditional | PDF ↗ |
| K880543 | UNI-PORT | Surgeon Surgical Instrumentation, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K871454 | MORGAN THERAPEUTIC LENS | Mortan, Inc. | 1987-06-19 | Traditional | PDF ↗ |
| K861203 | MULTI-SPIKE | Surgeon Surgical Instrumentation, Inc. | 1986-04-28 | Traditional | PDF ↗ |
| K860544 | BACSTOP FILTER IRRIGATION SUPPLY KIT | Staar Surgical Co. | 1986-04-04 | Traditional | PDF ↗ |
| K861013 | ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) | Ameritek, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K853243 | VISITEC IRRIGATION CONTROL SYSTEM | Visitec Co. | 1985-09-11 | Traditional | PDF ↗ |
| K845039 | OPERAID DISPOS. IRRIGATING KNIFE | Jedmed Instrument Co. | 1985-03-05 | Traditional | PDF ↗ |
| K841807 | OPERAID NUCLEUS | Jedmed Instrument Co. | 1984-11-21 | Traditional | PDF ↗ |
| K832787 | ELECATH HEPARIN COATED THERMAL DILUTION | Electro-Catheter Corp. | 1983-10-04 | Traditional | PDF ↗ |
| K831996 | MICRO SURGICAL HANDLE | Visitec Co. | 1983-07-12 | Traditional | PDF ↗ |
| K821897 | LENS | Mortan, Inc. | 1983-01-05 | Traditional | PDF ↗ |
| K820889 | ASPIRATOR/IRRIGATOR OR I/A UNIT | Mid Laboratories, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K820680 | DISPOSABLE TUBING SETS | Innovative Surgical Products, Inc. | 1982-04-09 | Traditional | PDF ↗ |
| K802332 | INTRAJECT | General Medical Engineering Corp. | 1980-12-22 | Traditional | PDF ↗ |
| K801822 | NU-VISION DISP. OPHTHALMIC DRESSING TRAY | Summit Optics, Inc. | 1980-09-30 | Traditional | PDF ↗ |
| K760820 | NALGENE EMERGENCY EYE WASH | Nagle Co. | 1976-10-20 | Traditional | PDF ↗ |
Product code KYG · Class I · Ophthalmic. Data: openFDA.