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Lithoskop

by Siemens Medical Solutions USA, Inc.

510(k) K070665

Lithoskop is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K070665 on 4 Jan 2008, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070665 Date4 Jan 2008ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LNS
Device class
Class II
Regulation
21 CFR Part 876.5990
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological).

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