FDA.reportPublic FDA data

LITHOCLAST

Primary DI
07613353143534
Brand
LITHOCLAST
Company
E.M.S. Electro Medical Systems S.A.
Model
FT-235US
Catalog number
M006840200K0
Device description
Swiss LithoClast Trilogy System Kit - US
Published
2018-03-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEOLithotriptor, Ultrasonic
FFKLithotriptor, Electro-Hydraulic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEOLithotriptor, UltrasonicGastroenterology, Urology2
FFKLithotriptor, Electro-HydraulicGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173234000
K181364000
K181997000
K182490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173234000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-01-10FEO
K181364000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-06-20FEO
K181997000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-08-30FEO
K182490000Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.A2018-10-09FEO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353143534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353143534076133531435347613353143534

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic/ultrasonic lithotripsy systemAn assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41229944700udi@ems-ch.com

Regulatory Flags#

DUNS number
481233849
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353313500GBT Machine StationDW-1002026-02-16
04262477320197SONOGELDV-1552025-09-02
04260153472031Swiss DolorClastDV-0332021-06-02
07613353170264Swiss DolorClastDV-0332020-06-03
07613353352356GBT Machine AIRFLOW Prophylaxis MasterFT-300#NFSFT-300 -01-202026-02-24
07613353180089Instruments A P PSFS-4582026-02-16
07613353180096Instruments PS PSR PSLFS-4592026-02-16
07613353225940GBT FLOWCONTROL x 4FV-112/A2026-02-16
07613353331184GBT Machine Wireless PedalEK-1055B2026-02-16
07613353334925AIR-FLOWFS-465FS-465/MX2026-02-16
07613353335847AIR-FLOWFS-477/US2026-02-16
07613353336837Instruments PSR PSLFS-4612026-02-16
07613353347802GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2B 3022026-02-16
07613353347819GBT Machine AIRFLOW Prophylaxis MasterFT-300FT-300 2BV022026-02-16
07613353348137AIR-FLOWFS-474FS-474/MX2026-02-16
07613353335113PIEZONFS-4552025-10-21
07613353341404PiezonEN-060#MX2025-10-21
07613353257224AIR-FLOW-PIEZONFT-229Default2025-10-20
07613353257323AIR-FLOW-PIEZONFT-229-2B-V022025-10-20
07613353257576AIR-FLOW-PIEZONFT-229-2B-3022025-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260667540257EL27-CompactWalz Elektronik GmbHFFK2025-11-12
06973204210763Electrohydraulic LithotriptorGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210787EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210794EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
06973204210800EHL ProbeGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.FFK2025-06-26
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FEO2024-09-03
07613353125929LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-09-03
00821925044173CYBERWANDGyrus ACMI, LLCFFK2024-07-25
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
00821925044180SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044210SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044227SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044234SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925044241SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043787SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043794SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043800SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043824SHOCKPULSEGyrus ACMI, LLCFEO2024-07-24
00821925043725SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043732SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043749SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043756SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043763SHOCKPULSEGyrus Acmi, Inc.FEO2024-07-24
00821925043817OlympusGyrus ACMI, LLCFEO2024-07-23
07613353222413LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311582LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353221836LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311568LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353311575LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353176686LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20