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) → MSR — Tubing, Replacement, Phacofragmentation Unit

# MSR · Tubing, Replacement, Phacofragmentation Unit

_Ophthalmic · 21 CFR 886.4150 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR

## Overview

- **Product Code:** MSR
- **Device Name:** Tubing, Replacement, Phacofragmentation Unit
- **Regulation:** [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## 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 (5 of 5)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K993361](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR/K993361.md) | TUBING EXTENSION SET | Hurricane Medical | Jan 4, 2000 | SESE |
| [K983448](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR/K983448.md) | ML UNIVERSAL TUBING | Med-Logics, Inc. | Dec 18, 1998 | SESE |
| [K980849](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR/K980849.md) | SURGIN KIT | Surgin Surgical Instrumentation, Inc. | Jul 9, 1998 | SESE |
| [K980100](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR/K980100.md) | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC  DAYPACK | Storz Instrument Co. | Jun 1, 1998 | SESE |
| [K972522](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR/K972522.md) | ML-DISPOSABLE PAK | Med-Logics, Inc. | Sep 30, 1997 | SESE |

## Top Applicants

- Med-Logics, Inc. — 2 clearances
- Hurricane Medical — 1 clearance
- Storz Instrument Co. — 1 clearance
- Surgin Surgical Instrumentation, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MSR)

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