Product code KYG
- Device name
- Device, Irrigation, Ocular Surgery
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4360
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010353 | MED-LOGICS DISPOSABLE ALK TUBING | Med-Logics, Inc. | 2001-04-27 |
| K003036 | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 | Retinalabs.Com | 2000-12-22 |
| K993591 | BLADEWORKS DISPOSABLE ALK TUBING | Blade Works, Inc. | 1999-12-28 |
| K981116 | SOVEREIGN CATARACT EXTRACTION SYSTEM | Allergan, Inc. | 1998-05-19 |
| K980647 | EYE IRRIGATOR MODEL #2020 | Eye-Deal Ocular Safety Products, Inc. | 1998-05-15 |
| K974561 | MOISTAIR FLUID AIR TUBING SET | American Medical Devices, Inc. | 1998-02-19 |
| K971173 | ML DISPOSABLE ALK TUBING | Med-Logics, Inc. | 1997-05-22 |
| K970161 | HEDGES CORNEAL WETTING PAK | Hedges Cwp, Inc. | 1997-03-25 |
| K954842 | D.O.R.C. VFI/VFE SYSTEM | Dutch Ophthalmic USA, Inc. | 1996-04-15 |
| K945171 | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE | Boston Surgical Products, Inc. | 1995-02-08 |
| K940392 | PEREGRINE PIC MINIPULATOR | Peregrine Surgical , Ltd. | 1994-08-23 |
| K935226 | I/V POLE | Optical Micro Systems, Inc. | 1994-02-16 |
| K935003 | ELECTRIC I/V POLE OR EIVP2 | Optical Micro Systems, Inc. | 1994-01-25 |
| K925921 | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | 1993-12-06 |
| K924999 | AUTOPOLE REGULATOR SYSTEM | Escalon Trek Medical | 1992-12-24 |
| K924052 | INFINITY MICRO IRRIGATOR | Infinity Surgical Technology, Inc. | 1992-12-23 |
| K922996 | MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS | Chiron Vision Corp. | 1992-07-27 |
| K922180 | LEWICKY O.R.S. TUBING | O.R. Specialties, Inc. | 1992-07-02 |
| K915808 | AQUEOUS PARACENTESIS PIPET | Visitec Co. | 1992-03-19 |
| K914587 | GRIESHABER AIR/FLUID TUBING SET | Grieshaber & Co. | 1992-01-23 |
| K904186 | SITE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | 1990-11-21 |
| K881517 | B & B I/A HANDPIECE | B&B Medical Assoc., Inc. | 1988-08-22 |
| K881518 | INFUSION HANDLE | B&B Medical Assoc., Inc. | 1988-08-22 |
| K881682 | ALCON SITE(R)-COMPATIBLE CASSETTE | Alcon Laboratories | 1988-07-01 |
| K880543 | UNI-PORT | Surgeon Surgical Instrumentation, Inc. | 1988-07-01 |
| K871454 | MORGAN THERAPEUTIC LENS | Mortan, Inc. | 1987-06-19 |
| K861203 | MULTI-SPIKE | Surgeon Surgical Instrumentation, Inc. | 1986-04-28 |
| K860544 | BACSTOP FILTER IRRIGATION SUPPLY KIT | Staar Surgical Co. | 1986-04-04 |
| K861013 | ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) | Ameritek, Inc. | 1986-03-31 |
| K853243 | VISITEC IRRIGATION CONTROL SYSTEM | Visitec Co. | 1985-09-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04251047930003 | Aspiration Handpiece | A1 Medical GmbH | 2026-05-29 |
| 04251047926204 | Irrigation Handpiece | A1 Medical GmbH | 2026-05-29 |
| 08052276026385 | Active Reservoir | AKTIVE SRL | 2024-01-11 |
| 08052276026378 | Passive Reservoir | AKTIVE SRL | 2024-01-11 |
| 08052276026361 | Set Bi-Manual I/A Handpieces 21G | AKTIVE SRL | 2024-01-11 |
| 08052276026354 | Set Bi-manual I/A Handpieces 23G | AKTIVE SRL | 2024-01-11 |
| 08052276019851 | High pressure injection/aspiration system for syringe - Connector F | AKTIVE SRL | 2023-06-16 |
| 08052276019691 | High pressure injection/aspiration system for syringe - Connector A | AKTIVE SRL | 2023-06-16 |
| 08052276019707 | High pressure injection/aspiration system for syringe - Connector A | AKTIVE SRL | 2023-06-16 |
| 08052276019714 | High pressure injection/aspiration system with syringe - Connector A | AKTIVE SRL | 2023-06-16 |
| 08052276019721 | High pressure injection/aspiration system for syringe - Connector B | AKTIVE SRL | 2023-06-16 |
| 08052276019929 | High pressure injection/aspiration system with syringe - Connector H | AKTIVE SRL | 2023-06-16 |
| 08052276019912 | High pressure injection/aspiration system for syringe - Connector H | AKTIVE SRL | 2023-06-16 |
| 08052276019905 | High pressure injection/aspiration system for syringe - Connector H | AKTIVE SRL | 2023-06-16 |
| 08052276019899 | High pressure injection/aspiration system with syringe - Connector G | AKTIVE SRL | 2023-06-16 |
| 08052276019882 | High pressure injection/aspiration system for syringe - Connector G | AKTIVE SRL | 2023-06-16 |
| 08052276019875 | High pressure injection/aspiration system for syringe - Connector G | AKTIVE SRL | 2023-06-16 |
| 08052276019868 | High pressure injection/aspiration system with syringe - Connector F | AKTIVE SRL | 2023-06-16 |
| 08052276019738 | High pressure injection/aspiration system for syringe - Connector B | AKTIVE SRL | 2023-06-16 |
| 08052276019844 | High pressure injection/aspiration system for syringe - Connector F | AKTIVE SRL | 2023-06-16 |
| 08052276019837 | High pressure injection/aspiration system with syringe - Connector E | AKTIVE SRL | 2023-06-16 |
| 08052276019820 | High pressure injection/aspiration system for syringe - Connector E | AKTIVE SRL | 2023-06-16 |
| 08052276019813 | High pressure injection/aspiration system for syringe - Connector E | AKTIVE SRL | 2023-06-16 |
| 08052276019806 | High pressure injection/aspiration system with syringe - Connector D | AKTIVE SRL | 2023-06-16 |
| 08052276019790 | High pressure injection/aspiration system for syringe - Connector D | AKTIVE SRL | 2023-06-16 |
| 08052276019783 | High pressure injection/aspiration system for syringe - Connector D | AKTIVE SRL | 2023-06-16 |
| 08052276019776 | High pressure injection/aspiration system with syringe - Connector C | AKTIVE SRL | 2023-06-16 |
| 08052276019769 | High pressure injection/aspiration system for syringe - Connector C | AKTIVE SRL | 2023-06-16 |
| 08052276019752 | High pressure injection/aspiration system for syringe - Connector C | AKTIVE SRL | 2023-06-16 |
| 08052276019745 | High pressure injection/aspiration system with syringe - Connector B | AKTIVE SRL | 2023-06-16 |