Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150) → HKP — Instrument, Vitreous Aspiration And Cutting, Battery-Powered # HKP · Instrument, Vitreous Aspiration And Cutting, Battery-Powered _Ophthalmic · 21 CFR 886.4150 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP ## Overview - **Product Code:** HKP - **Device Name:** Instrument, Vitreous Aspiration And Cutting, Battery-Powered - **Regulation:** [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) - **3rd-party reviewable:** yes ## Identification A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens. ## Classification Rationale Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, 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 (16 of 16) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K952558](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K952558.md) | AARON VAC 2 | Aaron Medical Industries | Mar 19, 1997 | SESE | | [K950056](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K950056.md) | THE GRIESHABER AXIAL CUTTER | Grieshaber & Co. | May 5, 1995 | SESE | | [K950287](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K950287.md) | UNIVIT PROBE | Medical Instrument Development Laboratories, Inc. | Apr 10, 1995 | SESE | | [K896622](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K896622.md) | VISITEC VITRECTOMY UNIT | Visitec Co. | Apr 4, 1990 | SESE | | [K890595](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K890595.md) | MENTOR ANTERIOR SEGMENT VITRECTOR | Mentor O & O, Inc. | Apr 17, 1989 | SESE | | [K832074](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K832074.md) | CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA | CooperVision, Inc. | Aug 1, 1983 | SESE | | [K822599](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K822599.md) | KEATES I/A SYSTEM FRIGITRONICS 4000 | Frigitronics of Connecticut, Inc. | Oct 6, 1982 | SESE | | [K813273](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K813273.md) | EMERGENCY POWER PAC (EMPAC) | Optical Micro Systems, Inc. | Dec 31, 1981 | SESE | | [K810152](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K810152.md) | X-VEE | Temporaty Surgical Systems | Mar 17, 1981 | SESE | | [K801231](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K801231.md) | EYE-VAC | Coburn Optical Ind., Inc. | Jul 21, 1980 | SESE | | [K791898](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K791898.md) | OCUTOME MODEL 8000 | Cooper Medical Devices Corp. | Oct 30, 1979 | SESE | | [K791000](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K791000.md) | VITREOUS SUCTION/CUTTER | Concept, Inc. | Sep 4, 1979 | SESE | | [K790893](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K790893.md) | STAT | Varian Assoc., Inc. | Aug 28, 1979 | SESE | | [K780852](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K780852.md) | CLINITEX VIS-X ASPIRATING ACCESSORY | Varian Assoc., Inc. | Nov 3, 1978 | SESE | | [K761353](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K761353.md) | VITEROUS SUCTION CUTTER | Concept, Inc. | Jan 5, 1977 | SESE | | [K760684](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP/K760684.md) | VISC X-VITREOUS ASPIRATING & CUT. INSTR | Varian Assoc., Inc. | Oct 5, 1976 | SESE | ## Top Applicants - Varian Assoc., Inc. — 3 clearances - Concept, Inc. — 2 clearances - Aaron Medical Industries — 1 clearance - Coburn Optical Ind., Inc. — 1 clearance - Cooper Medical Devices Corp. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HKP) **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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