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Dornier MedTech

by Dornier MedTech America, Inc. 70 variants

Dornier MedTech (K2011095) is a Class II device made by Dornier MedTech America, Inc., cleared under FDA 510(k) K161771 on 28 Jul 2016 and listed in FDA GUDID since 27 Jun 2023 (UDI-DI 00810116020515), 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) K161771

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 Number00810116020515 UDI-DI Date27 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK161771 Date28 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161771 decided 28 Jul 2016 Active
  • FDA GUDID UDI-DI 00810116020515 listed 27 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161771
  2. Listed FDA GUDID 00810116020515

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  • Withdrawn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
Dornier Medilas H 270 Micron Single Use Ball Tip Laser Fiber - LATAM, K2011095
Primary DI / UDI-DI
00810116020515
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 (K161771)

and 2 more cleared under K161771

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