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

Weights, Eyelid, Implantable

21 CFR 886.5700 / Ophthalmic
FDA source (opens on fda.gov)

NCB is the FDA product code for Weights, Eyelid, Implantable, a class II device type, regulated under 21 CFR 886.5700. FDA's definition for this code reads: "Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NCB
Device name
Weights, Eyelid, Implantable
FDA definition
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)
Regulation
21 CFR 886.5700
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
2

Clearances, product code NCB

By decision year
1 clearance under product code NCB with a decision year between 2021 and 2021, 2021 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NCB by decision year
YearClearances
20211

Applicants with the most clearances

Product code NCB
Applicants holding the most 510(k) clearances under product code NCB
ApplicantClearances
Fci (France Chirurgie Instrumentation) SAS1

Companies listing this code with FDA

Companies whose registered establishments list this code