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
HNLClass I

Probe, Lachrymal

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

HNL is the FDA product code for Probe, Lachrymal, a class I device type, regulated under 21 CFR 886.4350. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HNL
Device name
Probe, Lachrymal
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
10
Ingested recalls
1

Clearances, product code HNL

By decision year
10 clearances under product code HNL with a decision year between 1977 and 1984, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HNL by decision year
YearClearances
19771
19803
19811
19821
19831
19843

Applicants with the most clearances

Product code HNL
Applicants holding the most 510(k) clearances under product code HNL
ApplicantClearances
Concept, Inc.3
CooperVision, Inc.1
Ethicon, Inc1
Hansen Ophthalmic Development Lab1
JEDMED Instrument Company1
Narco Scientific1
Storz Instrument Co.1
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 145 companies shown, in name order