Skip to content

neXus 120-31-13C3

by Misonix, LLC

neXus 120-31-13C3 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 1 Jul 2020 (UDI-DI 00841626103580), 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 Number00841626103580 UDI-DI Date1 Jul 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 00841626103580 listed 1 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190160
  2. Listed FDA GUDID 00841626103580

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  • Withdrawn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
Wound therapy ultrasound system handpiece tip
Model / reference
120-31-13C3
Primary DI / UDI-DI
00841626103580
510(k) Number
FDA product code
LFL
GMDN term
Wound therapy ultrasound system handpiece tip
Device class
U
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wound therapy ultrasound system handpiece tip

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

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (10, all answered No)