Calcusplit

CALCUSPLIT® Lithotripsy Wire Probe

Registry build 21.09.26
1manufacturer
22catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code FFK
Manufacturer City Province Registered as Device types
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. Guangzhou Guangdong Manufacturer 4

Record

Regulatory record for Calcusplit
Listed by Karl Storz GmbH & Co. KG
FDA product code FFK
Device type Lithotriptor, Electro-Hydraulic
Device class Class 2
Regulation 21 CFR 876.4480
Record published 2016-09-23
Record revised 2024-10-21 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Calcusplit
Catalogue number Size Status
27632532 In distribution
27632631 In distribution
27634032 In distribution
27632536 In distribution
27634034 In distribution
27634033 In distribution
27632233 In distribution
27632234 In distribution
27632633 In distribution
27632232 In distribution
27632635 In distribution
27634031 In distribution
27632634 In distribution
27632636 In distribution
27630038 In distribution
27632434 In distribution
27630631 In distribution
27632535 In distribution
27632231 In distribution
27630020 In distribution
27630632 In distribution
27632534 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Lithoclast E.M.S. Electro Medical Systems S.A. 73
Riwolith Richard Wolf Gmbh 14
Lithotriptor, Electro-Hydraulic Karl Storz GmbH & Co. KG 12
US-Litho Richard Wolf Gmbh 11
Gyrus Acmi Gyrus Acmi, Inc. 11
Lithotriptor, Electro-Hydraulic Richard Wolf Gmbh 9
EHL-Probe Walz Elektronik Gmbh 8
Autolith Touch Northgate Technologies Inc. 7
StoneBreaker Cook Incorporated 7
Swiss LithoClast Select E.M.S. Electro Medical Systems S.A. 5
Rigid Pneumatic Probe Boston Scientific Corporation 5
Ultrasound Probe Boston Scientific Corporation 4

Showing 12 of 73. All products under Lithotriptor, Electro-Hydraulic

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer