Lithotripter, Shockwave (for Treating Gallbladder Stones)

Product Code: NCV

Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeAcoustic
Radition SafetyProduct
Annual ReportsNo

Products Classified as NCV

2216Lithotripter, Shockwave (for Treating Gallbladder Stones)

Total Product Life Cycle (TPLC) Devices

2216Lithotripter, Shockwave (for Treating Gallbladder Stones)

Pre-market Approvals for NCV

P970042MEDSTONE STS LITHOTRIPTERMEDSTONE INTL., INC.

Maude Adverse Events

SHOCKWAVEUNK2016-12-14
ESWL GAIT ATTACHMENT EQUIPMENTUNITED THERAPIES2011-01-26
GE HEALTHCAREGE HEALTHCARE2010-05-21
COMPACT DELTA LITHOTRIPTER UNIT 424DORNIER MEDTECH AMERICA, INC2008-03-20
COMPACT DELTA LITHOTRIPTER UNIT 424DORNIER MEDTECH AMERICA, INC.2008-03-20
KARL STORZSTORZ MEDICAL AG2007-05-21
**STORZ MEDICAL AG2007-05-21
DOLI SDORNIER MEDICAL SYSTEMS, INC.2001-04-11

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