ShockPulse SPL-CSS
ShockPulse SPL-CSS is a Class II device made by Gyrus Acmi, Inc., cleared under FDA 510(k) K142428 on 13 Nov 2014 and listed in FDA GUDID since 3 Mar 2020 (UDI-DI 00821925043688), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00821925043688 | Date3 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142428 | Date13 Nov 2014 | StatusActive |
Official records
- AccessGUDID record 00821925043688
- FDA 510(k) database K142428
Across registries
- FDA 510(k) K142428 decided 13 Nov 2014 Active
- FDA GUDID UDI-DI 00821925043688 listed 3 Mar 2020 Listed
Recalls
-
- Terminated Z-2197-2020
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
Timeline
- Cleared FDA 510(k) K142428
- Listed FDA GUDID 00821925043688
- Recall initiated FDA recalls Z-2197-2020
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ShockPulse
- Generic name
- Pneumatic/ultrasonic lithotripsy system
- Model / reference
- SPL-CSS
- Primary DI / UDI-DI
- 00821925043688
- 510(k) Number
- FDA product code
- FEO
- GMDN term
- Pneumatic/ultrasonic lithotripsy system
- Device class
- Class II
- Regulation number
- 876.4480
- GUDID distribution status
- In Commercial Distribution