FDA Product Code NMK: Trocar, 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).
Leading manufacturers include Innovative Health, LLC.
2
Total
2
Cleared
164d
Avg days
2020
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
60d
recently vs 268d historically
FDA 510(k) Cleared Trocar, Reprocessed Devices (Product Code NMK)
2 devices
Cleared
Oct 19, 2026
Reprocessed BRK Transseptal Needle
Innovative Health, LLC
Cardiovascular
60d
Cleared
Jul 22, 2020
Reprocessed BRK Transseptal Needle
Innovative Health, LLC
Cardiovascular
268d
About Product Code NMK - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code NMK since 2020, with 2 receiving FDA clearance (average review time: 164 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - NMK Product Code
Recent submissions under NMK have taken an average of 60 days to reach a decision - down from 268 days historically, suggesting improved FDA processing for this classification.
NMK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →