Tubing, Replacement, Phacofragmentation Unit
Replacement Tubing for a Phacofragmentation Unit is a sterile fluid management accessory used with ophthalmic phacofragmentation or phacoemulsification systems during cataract surgery, allowing for the irrigation and aspiration of ocular fluids. It is classified as FDA Class 2, requiring 510(k) clearance, with product code MSR under 21 CFR 886.4150 in the Ophthalmic specialty. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MSR
- Device Class
- FDA class 2
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K993361 | TUBING EXTENSION SET | Jan 04, 2000 | Substantially Equivalent | Hurricane Medical |
| K983448 | ML UNIVERSAL TUBING | Dec 18, 1998 | Substantially Equivalent | Med-Logics, Inc. |
| K980849 | SURGIN KIT | Jul 09, 1998 | Substantially Equivalent | Surgin Surgical Instrumentation, Inc. |
| K980100 | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | Jun 01, 1998 | Substantially Equivalent | Storz Instrument Co. |
| K972522 | ML-DISPOSABLE PAK | Sep 30, 1997 | Substantially Equivalent | Med-Logics, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.