FDA.reportPublic FDA data

Lithotripsy Probe 9FR 54cm

Primary DI
10817183020179
Brand
Lithotripsy Probe 9FR 54cm
Company
NORTHGATE TECHNOLOGIES INC.
Model
9-900-54
Device description
9FR 54cm Lithotripsy Probe for use with Autolith Lithotripters
Published
2016-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K914516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9145160009 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATIONNorthgate Technologies, Inc.1992-01-07FFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817183020179PackageGS13In Commercial Distribution
00817183020172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081718302017910817183020179
00817183020172008171830201728171830201720817183020172

GMDN Terms#

Term, Definition table
TermDefinition
Electrohydraulic/pneumatic lithotripsy system probe, urinary, single-useA sterile, slender, rod-like device intended to be used as part of an intracorporeal lithotripsy system to transmit shock waves from electrohydraulic or pneumatic sources directly to a calculus in the urinary tract (i.e., kidneys, ureters, and bladder), providing high-speed fragmentation of the calculus in situ. It is typically made of high-grade stainless steel, may be rigid or semi-flexible, and is available in a variety of sizes and lengths. It may be introduced endoscopically through a natural body orifice or a surgically made opening. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
627969264
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817183020844Dual CO2 Cylinder Hose7-650-502025-03-31
10817183020841Dual CO2 Cylinder Hose7-650-502025-03-31
00817183020820StimSite AM-VY1 AdapterAM-VY12024-07-10
00817183020813PUREPNEUMO Tubing Set7-650-012024-07-09
10817183020810PUREPNEUMO Tubing Set7-650-012024-07-09
00817183020769StimSite Signal BoxAM-1012024-04-29
00817183020417Suction Tubing Set7-510-442019-02-22
00817183020622Suction Tubing Set72-00327-02019-06-19
00817183020776StimSite Activation CardAM-21012023-11-21
00817183020660NEBULAE SRS Tubing Set7-510-572023-02-14
00817183020684NEBULAE SRS Laparoscopic Surgical Pump7-700-002023-02-14
00817183020714N/A7220399572-00273-02021-01-05
00817183020721N/A720597272-00166-02021-01-05
00817183020738N/A427072-00146-02021-01-05
00817183020196CO2 Hose and Yoke7-510-092016-10-13
00817183020202CO2 Hose and Yoke Shuttle Valve System7-510-502016-10-13
00817183020257CO2 Hose and DISS7-510-342016-10-14
00817183020264CO2 Hose and DIN7-510-362016-10-14
00817183020226Insufflation Tubing, Laparoscopic7-510-522016-10-13
00817183020301Insufflation Tubing, Gen Use 15mm7-510-152016-10-14

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.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