NMK — Trocar, Reprocessed Class II

FDA Device Classification

Classification Details

Product Code
NMK
Device Class
Class II
Regulation Number
870.1390
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

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).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192998innovative healthReprocessed BRK Transseptal NeedleJuly 22, 2020