Lithotriptor, Ultrasonic
The Ultrasonic Lithotriptor is a device that uses high-frequency sound waves to fragment urinary tract or biliary stones into smaller pieces that can be passed or removed. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FEO, regulated under 21 CFR 876.4480, within the Gastroenterology, Urology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FEO
- Device Class
- FDA class 2
- Regulation Number
- 876.4480
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230893 | Swiss LthoClast Trilogy | Oct 23, 2023 | Substantially Equivalent | E.M.S Electro Medical Systems S.A |
| K182490 | Swiss LithoClast Trilogy | Oct 09, 2018 | Substantially Equivalent | E.M.S Electro Medical Systems S.A |
| K181997 | Swiss LithoClast Trilogy | Aug 30, 2018 | Substantially Equivalent | E.M.S Electro Medical Systems S.A |
| K181364 | Swiss LithoClast Trilogy | Jun 20, 2018 | Substantially Equivalent | E.M.S Electro Medical Systems S.A |
| K173234 | Swiss LithoClast Trilogy | Jan 10, 2018 | Substantially Equivalent | E.M.S Electro Medical Systems S.A |
| K171024 | ShockPulse-SE Lithotripsy System | Aug 21, 2017 | Substantially Equivalent | Cybersonics, Inc. |
| K142428 | Shock Pulse-SE Lithotripsy System CYBERWAND II | Nov 13, 2014 | Substantially Equivalent | Cybersonics, Inc. |
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | Nov 22, 1999 | Substantially Equivalent | Fibra Sonics, Inc. |
| K973251 | KSEA CALCUSON | Jun 22, 1998 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K920235 | ULTRASOUND GENERATOR MODLE 2270 | Dec 07, 1992 | Substantially Equivalent | Richard Wolf Medical Instruments Corp. |
| K873367 | OLYMPUS LUS ULTRASONIC LITHOTRIPTER | Nov 30, 1987 | Substantially Equivalent | Olympus Corp. |
| K850298 | ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM | Mar 05, 1985 | Substantially Equivalent | Cabot Medical Corp. |
| K843101 | KARL STORZ 27086KC ULTRASONIC LITHOTRI | Dec 11, 1984 | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | Dec 11, 1984 | Substantially Equivalent | Fibra Sonics, Inc. |
FEI Numbers
This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.