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

Retractor, Ophthalmic

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

HNI is the FDA product code for Retractor, Ophthalmic, 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 no recalls.

Classification record

Product code
HNI
Device name
Retractor, Ophthalmic
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
0

Clearances, product code HNI

By decision year
2 clearances under product code HNI with a decision year between 1977 and 1999, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HNI by decision year
YearClearances
19771
19991

Applicants with the most clearances

Product code HNI
Applicants holding the most 510(k) clearances under product code HNI
ApplicantClearances
Concept, Inc.1
Karl Storz Endoscopy-America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 148 companies shown, in name order