510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MSRClass II

Tubing, Replacement, Phacofragmentation Unit

21 CFR 886.4150 / Ophthalmic
FDA source (opens on fda.gov)

MSR is the FDA product code for Tubing, Replacement, Phacofragmentation Unit, a class II device type, regulated under 21 CFR 886.4150. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MSR
Device name
Tubing, Replacement, Phacofragmentation Unit
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code MSR

By decision year
5 clearances under product code MSR with a decision year between 1997 and 2000, 1998 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code MSR by decision year
YearClearances
19971
19983
20001

Applicants with the most clearances

Product code MSR
Applicants holding the most 510(k) clearances under product code MSR
ApplicantClearances
Med-logics Inc2
Hurricane Medical1
Storz Instrument Co.1
Surgin Surgical Instrumentation, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code