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ShockPulse Lithotripsy Generator SPL-G

by Cybersonics Inc

ShockPulse Lithotripsy Generator SPL-G is a Class II device made by Cybersonics Inc, listed in FDA GUDID since 30 Apr 2016 (UDI-DI 00855279005054), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855279005054 UDI-DI Date30 Apr 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
ShockPulse Lithotripsy Generator
Generic name
Pneumatic/ultrasonic lithotripsy system
Model / reference
SPL-G
Primary DI / UDI-DI
00855279005054
FDA product code
FEO
GMDN term
Pneumatic/ultrasonic lithotripsy system
Device class
Class II
Regulation number
876.4480
GUDID distribution status
Not in Commercial Distribution

Other devices from Cybersonics Inc

See all devices from Cybersonics Inc →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)