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Dornier MedTech

by Dornier MedTech America, Inc. 70 variants

Dornier MedTech (DUR400R) is a Class II device made by Dornier MedTech America, Inc., cleared under FDA 510(k) K123385 on 14 Dec 2012 and listed in FDA GUDID since 27 Jun 2023 (UDI-DI 00810116023509), active as of 16 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 16 Oct 2026

Documents

510(k) K123385

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 16 Oct 2026.

Regulatory status

as of registry sync 16 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810116023509 UDI-DI Date27 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK123385 Date14 Dec 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123385 decided 14 Dec 2012 Active
  • FDA GUDID UDI-DI 00810116023509 listed 27 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123385
  2. Listed FDA GUDID 00810116023509

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Laser lithotripsy system
Model / Ref / Catalog
Holmium 400um 3M Fiber 3ST 10X Use - LATAM Non-RFID Reusable, DUR400R
Primary DI / UDI-DI
00810116023509
510(k) Number
FDA product code
GEX
GMDN term
Laser lithotripsy system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Laser lithotripsy system

Cleared under the same submission (K123385)

and 8 more cleared under K123385

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

Other devices from Dornier MedTech America, Inc.

See all devices from Dornier MedTech America, Inc. →

Properties

  • Supplied sterile
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)