FDA product code MSR: Tubing, Replacement, Phacofragmentation Unit
MSR is the FDA product code for tubing, replacement, phacofragmentation unit. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel. FDA has cleared 5 510(k) submissions under MSR, from 4 different applicants. The average 510(k) review took 110 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | Tubing, Replacement, Phacofragmentation Unit |
| Device class | Class II |
| Regulation | 21 CFR 886.4150 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MSR clearance
Top MSR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med-Logics, Inc. | 2 | 1998-12-18 |
| Hurricane Medical | 1 | 2000-01-04 |
| Surgin Surgical Instrumentation, Inc. | 1 | 1998-07-09 |
| Storz Instrument Co. | 1 | 1998-06-01 |
Most recent MSR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993361 | Hurricane Medical | TUBING EXTENSION SET | 2000-01-04 | 90 |
| K983448 | Med-Logics, Inc. | ML UNIVERSAL TUBING | 1998-12-18 | 79 |
| K980849 | Surgin Surgical Instrumentation, Inc. | SURGIN KIT | 1998-07-09 | 154 |
| K980100 | Storz Instrument Co. | STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK | 1998-06-01 | 140 |
| K972522 | Med-Logics, Inc. | ML-DISPOSABLE PAK | 1997-09-30 | 85 |
Recalls for MSR devices
openFDA lists no recalls for product code MSR.
Frequently asked questions
What is FDA product code MSR?
MSR is the FDA product code for tubing, replacement, phacofragmentation unit. It is a Class II device, regulated under 21 CFR 886.4150 and reviewed by the Ophthalmic panel.
What device class is MSR?
Class II, regulation 21 CFR 886.4150. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MSR?
Across 5 cleared submissions the average was 110 days from receipt to decision (median 90).
Which companies have the most MSR clearances?
Med-Logics, Inc. (2); Hurricane Medical (1); Surgin Surgical Instrumentation, Inc. (1); Storz Instrument Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MSR
- Run a recall and safety report across every MSR manufacturer
- Watch product code MSR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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