510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HNNClass I

Knife, Ophthalmic

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

HNN is the FDA product code for Knife, Ophthalmic, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 54 510(k) clearances under this code, the most recent dated , and 155 recalls.

Classification record

Product code
HNN
Device name
Knife, 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
54
Ingested recalls
155

Clearances, product code HNN

By decision year
54 clearances under product code HNN with a decision year between 1976 and 2011, 1986 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code HNN by decision year
YearClearances
19763
19781
19792
19813
19823
19834
19845
198511
198613
19874
19883
19921
20111

Applicants with the most clearances

Product code HNN
Applicants holding the most 510(k) clearances under product code HNN
ApplicantClearances
Myocure, Inc.5
Keeler Instruments, Inc.4
Med-Tech Develoment Corp.3
Rudolph Beaver, Inc.3
Sharpoint, Inc.3
Storz Instrument Co.3
V. Mueller O.V. Baxter Healthcare Corp.3
Advanced Surgical Products, Inc.2
Alphamedix, Inc.2
Cerenovus, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 190 companies shown, in name order