510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NMKClass II

Trocar, Reprocessed

21 CFR 870.1390 / Cardiovascular
FDA source (opens on fda.gov)

NMK is the FDA product code for Trocar, Reprocessed, a class II device type, regulated under 21 CFR 870.1390. FDA's definition for this code reads: "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 one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NMK
Device name
Trocar, Reprocessed
FDA 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).
Regulation
21 CFR 870.1390
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code NMK

By decision year
1 clearance under product code NMK with a decision year between 2020 and 2020, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NMK by decision year
YearClearances
20201

Applicants with the most clearances

Product code NMK
Applicants holding the most 510(k) clearances under product code NMK
ApplicantClearances
Innovative Health, LLC.1

Companies listing this code with FDA

Companies whose registered establishments list this code