Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4360](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4360) → KYG — Device, Irrigation, Ocular Surgery # KYG · Device, Irrigation, Ocular Surgery _Ophthalmic · 21 CFR 886.4360 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG ## Overview - **Product Code:** KYG - **Device Name:** Device, Irrigation, Ocular Surgery - **Regulation:** [21 CFR 886.4360](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4360) - **Device Class:** 1 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K010353.md) | MED-LOGICS DISPOSABLE ALK TUBING | Med-Logics, Inc. | Apr 27, 2001 | SESE | | [K003036](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K003036.md) | TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025 | Retinalabs.Com | Dec 22, 2000 | SESE | | [K993591](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K993591.md) | BLADEWORKS DISPOSABLE ALK TUBING | Blade Works, Inc. | Dec 28, 1999 | SESE | | [K981116](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K981116.md) | SOVEREIGN CATARACT EXTRACTION SYSTEM | Allergan, Inc. | May 19, 1998 | SESE | | [K980647](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K980647.md) | EYE IRRIGATOR MODEL #2020 | Eye-Deal Ocular Safety Products, Inc. | May 15, 1998 | SESE | | [K974561](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K974561.md) | MOISTAIR FLUID AIR TUBING SET | American Medical Devices, Inc. | Feb 19, 1998 | SESE | | [K971173](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K971173.md) | ML DISPOSABLE ALK TUBING | Med-Logics, Inc. | May 22, 1997 | SESE | | [K970161](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K970161.md) | HEDGES CORNEAL WETTING PAK | Hedges Cwp, Inc. | Mar 25, 1997 | SESE | | [K954842](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K954842.md) | D.O.R.C. VFI/VFE SYSTEM | Dutch Ophthalmic USA, Inc. | Apr 15, 1996 | SESE | | [K945171](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K945171.md) | DISPOSABLE & RESUABLE IRRIGATION/ASPIRATION HANDPIECE | Boston Surgical Products, Inc. | Feb 8, 1995 | SESE | | [K940392](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K940392.md) | PEREGRINE PIC MINIPULATOR | Peregrine Surgical , Ltd. | Aug 23, 1994 | SESE | | [K935226](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K935226.md) | I/V POLE | Optical Micro Systems, Inc. | Feb 16, 1994 | SESE | | [K935003](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K935003.md) | ELECTRIC I/V POLE OR EIVP2 | Optical Micro Systems, Inc. | Jan 25, 1994 | SESE | | [K925921](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K925921.md) | MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE | Site Microsurgical Systems, Inc. | Dec 6, 1993 | SESE | | [K924999](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K924999.md) | AUTOPOLE REGULATOR SYSTEM | Escalon Trek Medical | Dec 24, 1992 | SESE | | [K924052](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K924052.md) | INFINITY MICRO IRRIGATOR | Infinity Surgical Technology, Inc. | Dec 23, 1992 | SESE | | [K922996](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K922996.md) | MODIFIED SITE DIAPHRAGM CASSETTE FOR OPHTHALMICS | Chiron Vision Corp. | Jul 27, 1992 | SESE | | [K922180](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K922180.md) | LEWICKY O.R.S. TUBING | O.R. Specialties, Inc. | Jul 2, 1992 | SESE | | [K915808](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K915808.md) | AQUEOUS PARACENTESIS PIPET | Visitec Co. | Mar 19, 1992 | SESE | | [K914587](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG/K914587.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/KYG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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