Olympus Lus Ultrasonic Lithotripter
FDA 510(k) K873367 · Olympus Corp.
510(k) numberK873367
Submission
- Device name
- Olympus Lus Ultrasonic Lithotripter
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- August 21, 1987
- Decision date
- November 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FEO – Lithotriptor, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4480
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K230893 | Swiss LthoClast TrilogyFEO · Traditional | E.M.S Electro Medical Systems S.A | 10/23/2023SE |
| K182490 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 10/09/2018SE |
| K181997 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 08/30/2018SE |
| K181364 | Swiss LithoClast TrilogyFEO · Special | E.M.S Electro Medical Systems S.A | 06/20/2018SE |
| K173234 | Swiss LithoClast TrilogyFEO · Traditional | E.M.S Electro Medical Systems S.A | 01/10/2018SE |
| K171024 | ShockPulse-SE Lithotripsy SystemFEO · Traditional | Cybersonics, Inc. | 08/21/2017SE |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND IIFEO · Traditional | Cybersonics, Inc. | 11/13/2014SE |
| K993046 | Fibra Sonics Ultrasonic Lithotriptor Lithosonic, Model LS-2000FEO · Traditional | Fibra Sonics, Inc. | 11/22/1999SE |
| K973251 | Ksea CalcusonFEO · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/22/1998SE |
| K920235 | Ultrasound Generator Modle 2270FEO · Traditional | Richard Wolf Medical Instruments Corp. | 12/07/1992SE |
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Questions and answers
When was Olympus Lus Ultrasonic Lithotripter cleared by the FDA?
Olympus Lus Ultrasonic Lithotripter (K873367) received a 510(k) decision of Substantially Equivalent on November 30, 1987, 101 days after the submission was received.
What is the product code of K873367?
The FDA product code is FEO – Lithotriptor, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 876.4480.