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

Stand, Instrument, Ophthalmic, Non-Powered

21 CFR 886.1860 / Ophthalmic
FDA source (opens on fda.gov)

HMG is the FDA product code for Stand, Instrument, Ophthalmic, Non-Powered, a class I device type, regulated under 21 CFR 886.1860. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HMG
Device name
Stand, Instrument, Ophthalmic, Non-Powered
Regulation
21 CFR 886.1860
Device class
Class I
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
4
Ingested recalls
0

Clearances, product code HMG

By decision year
4 clearances under product code HMG with a decision year between 1984 and 1990, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HMG by decision year
YearClearances
19841
19871
19881
19901

Applicants with the most clearances

Product code HMG
Applicants holding the most 510(k) clearances under product code HMG
ApplicantClearances
Gorsk, Inc.1
JEDMED Instrument Company1
Site Microsurgical Systems, Inc.1
Woodlyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order