FDA.reportPublic FDA data

EHL Probe

Primary DI
06973204210787
Brand
EHL Probe
Company
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Model
SCDG - AS
Published
2025-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FFKLithotriptor, Electro-Hydraulic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243032000EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.2025-03-21FFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973204210787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973204210787069732042107876973204210787

GMDN Terms#

Term, Definition table
TermDefinition
Electrohydraulic lithotripsy systemAn assembly of devices that uses plasma-induced shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. It typically comprises a generator-powered probe which fires energy pulses at the stone's centre while the probe is irrigated with a saline solution. The collapse of the resulting plasma bubble causes a hydraulic shock that fragments the stone into several pieces which can then be removed using surgical instruments (e.g., a grasping instrument or stone basket).

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
540482563
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973204211760Laser FiberPT-OF-A-S2026-04-03
06973204211777Laser FiberPT-OF-B-S2026-04-03
06973204211784Laser FiberPT-OF-C-S2026-04-03
06973204211791Laser FiberPT-OF-D-S2026-04-03
06973204211807Laser FiberPT-OF-E-S2026-04-03
06973204211814Laser FiberPT-OF-F-S2026-04-03
06973204212255Holmium Laser Therapeutic ApparatusHZ-402026-04-03
06973204212378Holmium Laser SystemPotent HP1402026-04-03
06973204212385Holmium Laser SystemPotent HP1502026-04-03
06973204212248Holmium Laser Therapeutic ApparatusHZ-E2026-04-02
06973204212361Holmium Laser SystemPotent HP902026-04-02
06973204212422Holmium Laser SystemPotent HP1002026-04-02
06973204212439Holmium Laser SystemPotent HP1202026-04-02
06973204212224Holmium Laser Therapeutic ApparatusHZ-A2026-04-01
06973204212231Holmium Laser Therapeutic ApparatusHZ-B2026-04-01
06973204212392Thulium Fiber Laser SystemTFL-A2026-04-01
06973204212408Thulium Fiber Laser SystemTFL-B2026-04-01
06973204210763Electrohydraulic LithotriptorTCS-B3-II2025-06-26
06973204210794EHL ProbeSCDG - BS2025-06-26
06973204210800EHL ProbeSCDG - CS2025-06-26

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
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.FFK2024-09-03
00821925044173CYBERWANDGyrus ACMI, LLCFFK2024-07-25
00821925043596CYBERWANDGyrus Acmi, Inc.FFK2024-07-25
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
07613353312046LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2024-03-20
07613353214159LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
07613353214203LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2023-11-22
04260667540011EL27-CompactWalz Elektronik GmbHFFK2023-10-25
04260667540059EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540097EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540110EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540134EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540158EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540172EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540196EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
04260667540219EHL-ProbeWalz Elektronik GmbHFFK2023-10-25
07290016498455LithospecMEDISPEC LTD.FFK2023-06-08
07613353187101SWISS DolorClastE.M.S. Electro Medical Systems S.A.FFK2022-10-28
07613353001940LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17
07613353001964LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17
07613353062378LITHOCLASTE.M.S. Electro Medical Systems S.A.FFK2021-09-17