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SonaStar CFSM6-H190

by Misonix, LLC

SonaStar CFSM6-H190 is a Class II device made by Misonix, LLC, cleared under FDA 510(k) K062471 on 26 Oct 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00841626100183), 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) K062471

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 Number00841626100183 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062471 Date26 Oct 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062471 decided 26 Oct 2006 Active
  • FDA GUDID UDI-DI 00841626100183 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062471
  2. Listed FDA GUDID 00841626100183

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SonaStar
Generic name
Ultrasonic surgical system handpiece cooling sleeve
Model / reference
CFSM6-H190
Primary DI / UDI-DI
00841626100183
510(k) Number
FDA product code
GEI, LFL
GMDN term
Ultrasonic surgical system handpiece cooling sleeve
Device class
Class II
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 (K062471)

and 8 more cleared under K062471

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

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)