MSR
5 FDA 510(k) clearances · Product code
90 daysmedian time to decision
154 days90th percentile
5clearances measured
FDA profile
- Official device name
- Tubing, Replacement, Phacofragmentation Unit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TUBING EXTENSION SET (K993361) | Hurricane Medical | 2000-01-04 |
| ML UNIVERSAL TUBING (K983448) | Med-Logics, Inc. | 1998-12-18 |
| SURGIN KIT (K980849) | Surgin Surgical Instrumentation, Inc. | 1998-07-09 |
| STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK (K980100) | Storz Instrument Co. | 1998-06-01 |
| ML-DISPOSABLE PAK (K972522) | Med-Logics, Inc. | 1997-09-30 |
Track MSR automatically
Every clearance here is in the API, with alerts when new ones post.