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Router Assembly 79

by Neocoil, LLC

Router Assembly 79 is a Class II device made by Neocoil, LLC, cleared under FDA 510(k) K173409 on 16 Feb 2018 and listed in FDA GUDID since 26 Apr 2018 (UDI-DI 00856181003794), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K173409

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856181003794 UDI-DI Date26 Apr 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK173409 Date16 Feb 2018IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173409 decided 16 Feb 2018 Active
  • FDA GUDID UDI-DI 00856181003794 listed 26 Apr 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173409
  2. Listed FDA GUDID 00856181003794

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Router Assembly
Generic name
Headphones
Model / reference
79
Primary DI / UDI-DI
00856181003794
510(k) Number
FDA product code
LNH
GMDN term
Headphones
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Headphones

Cleared under the same submission (K173409)

and 1 more cleared under K173409

Similar devices

Also classified as Headphones.

Similar devices

Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).

Other devices from Neocoil, LLC

See all devices from Neocoil, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)