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neXus 100-25-0003

by Misonix, LLC

neXus 100-25-0003 is a device classified as Unclassified made by Misonix, LLC, cleared under FDA 510(k) K190160 on 30 May 2019 and listed in FDA GUDID since 24 Feb 2020 (UDI-DI 00841626102866), 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) K190160

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 Number00841626102866 UDI-DI Date24 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190160 Date30 May 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190160 decided 30 May 2019 Active
  • FDA GUDID UDI-DI 00841626102866 listed 24 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190160
  2. Listed FDA GUDID 00841626102866

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
neXus
Generic name
Ultrasonic surgical system handpiece cooling sleeve
Model / reference
100-25-0003
Primary DI / UDI-DI
00841626102866
510(k) Number
FDA product code
LFL, GEI
GMDN term
Ultrasonic surgical system handpiece cooling sleeve
Device class
U
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Ultrasonic surgical system handpiece cooling sleeve

Cleared under the same submission (K190160)

and 8 more cleared under K190160

Similar devices

Other devices filed under FDA product code LFL (Instrument, Ultrasonic Surgical).

Other devices from Misonix, LLC

See all devices from Misonix, LLC →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)