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
K183400Substantially Equivalent

EnVisio Navigation Sytem

Elucent Medical Inc, Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183400 is the FDA 510(k) clearance record for EnVisio Navigation Sytem, a class II device, cleared for Elucent Medical, Inc. on under FDA product code NEU (Marker, Radiographic, Implantable). FDA records list 4 510(k) clearances for Elucent Medical, Inc., from to . As of , FDA records show one recall naming K183400.

Clearance record

Decision date
Received
(105 days to decision)
Product code
NEU Marker, Radiographic, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Elucent Medical, Inc. 7480 Flying Cloud Dr., Suite 110, Eden Prairie MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEU

Trailing 12 months
4 clearances under product code NEU in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NEU, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260