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

Prism, Bar, Ophthalmic

21 CFR 886.1650 / Ophthalmic
FDA source (opens on fda.gov)

HKW is the FDA product code for Prism, Bar, Ophthalmic, a class I device type, regulated under 21 CFR 886.1650. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HKW
Device name
Prism, Bar, Ophthalmic
Regulation
21 CFR 886.1650
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code HKW

By decision year
2 clearances under product code HKW with a decision year between 1985 and 1991, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HKW by decision year
YearClearances
19851
19911

Applicants with the most clearances

Product code HKW
Applicants holding the most 510(k) clearances under product code HKW
ApplicantClearances
National Reading Service1
Roseburg SA1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order