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MS-Pen 92-020

by Söring GmbH

MS-Pen 92-020 is a Class II device made by Söring GmbH, cleared under FDA 510(k) K992026 on 23 Sep 1999 and listed in FDA GUDID since 17 Sep 2016 (UDI-DI 04250321519194), active as of 23 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 23 Oct 2026

Documents

510(k) K992026

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04250321519194 UDI-DI Date17 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK992026 Date23 Sep 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K992026 decided 23 Sep 1999 Active
  • FDA GUDID UDI-DI 04250321519194 listed 17 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K992026
  2. Listed FDA GUDID 04250321519194

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MS-Pen
Generic name
Soft-tissue ultrasonic surgical system handpiece, reusable
Model / reference
92-020
Primary DI / UDI-DI
04250321519194
510(k) Number
FDA product code
BTA
GMDN term
Soft-tissue ultrasonic surgical system handpiece, reusable
Device class
Class II
Regulation number
878.4780
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 2.0 Millimeter
Length — 35 Millimeter

Similar devices

Other devices filed under FDA product code BTA (Pump, Portable, Aspiration (Manual Or Powered)).

Other devices from Söring GmbH

  • 612K0038-10

    Class II
  • MS-Pen 92-021

    Class II
  • 612K0037-10

    Class II
  • 240K0094

    Class II

See all devices from Söring GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)