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

Knife, Ophthalmic, Reprocessed

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

NLA is the FDA product code for Knife, Ophthalmic, Reprocessed, a class I device type, regulated under 21 CFR 886.4350. FDA's definition for this code reads: "Used for cutting soft tissue in or around the eye. Surgical knife same as product code HNN, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf)". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NLA
Device name
Knife, Ophthalmic, Reprocessed
FDA definition
Used for cutting soft tissue in or around the eye. Surgical knife same as product code HNN, except this one is reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NLA.