Product code NLB

Device name

Trocar, Tracheal, Laryngeal, Sinus, Reprocessed

Medical specialty

Ear, Nose, Throat

Device class

1

Regulation number

874.4420

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

Same as KBG, KAB, and KCI but need one code for reprocessing. 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).

Source

FDA openFDA device classification dataset