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

Needle, Ophthalmic Suturing

21 CFR 886.4350 / Ophthalmic
FDA source (opens on fda.gov)

HNM is the FDA product code for Needle, Ophthalmic Suturing, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
HNM
Device name
Needle, Ophthalmic Suturing
Regulation
21 CFR 886.4350
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
2
Ingested recalls
2

Clearances, product code HNM

By decision year
2 clearances under product code HNM with a decision year between 1978 and 1985, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HNM by decision year
YearClearances
19781
19851

Applicants with the most clearances

Product code HNM
Applicants holding the most 510(k) clearances under product code HNM
ApplicantClearances
Edward Weck, Inc.1
Optical Micro Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 76 companies shown, in name order