Gyrus Acmi
Electrohydraulic Lithotripsy Probe 1.9 FR (0.633 mm) X 120 CM
1manufacturer
11catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 4 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | FFK |
| Device type | Lithotriptor, Electro-Hydraulic |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4480 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K980492 |
| Record published | 2016-10-13 |
| Record revised | 2024-09-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 3, pack of 6 |
| Distribution end date | 2026-03-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E-5F | In distribution | |
| E4-9F | Withdrawn | |
| CW-USLPC | Withdrawn | |
| AEH-4FS | Withdrawn | |
| E4-2F | Withdrawn | |
| AEH-4EC | Withdrawn | |
| E-9F | Withdrawn | |
| E-1F | Withdrawn | |
| AEH-4 | Withdrawn | |
| AEH-4PC | Withdrawn | |
| E-3F | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lithoclast | E.M.S. Electro Medical Systems S.A. | 73 |
| Calcusplit | Karl Storz GmbH & Co. KG | 22 |
| Riwolith | Richard Wolf Gmbh | 14 |
| Lithotriptor, Electro-Hydraulic | Karl Storz GmbH & Co. KG | 12 |
| US-Litho | Richard Wolf Gmbh | 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
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Gyrus Acmi, Inc. | 510(k) number | 2007-05-23 | Not classified | Other | Sterilization Instructions not adequate for sterilizing. | 53 units | 2010-05-25 |
| Acmi Corporation | 510(k) number | 2004-04-30 | Not classified | Other | Product sterility may be compromised due to the lack of package seal integrity | 1479 boxes (3 probes/box) | 2005-06-13 |
| Acmi Corporation | 510(k) number | 2004-04-30 | Not classified | Other | Product sterility may be compromised due to the lack of package seal integrity | 541 boxes(3 probes/box) | 2005-06-13 |
| Acmi Corporation | 510(k) number | 2004-04-30 | Not classified | Other | Product sterility may be compromised due to the lack of package seal integrity | 186 boxes ( 6 probes/box) | 2005-06-13 |
| Acmi Corporation | 510(k) number | 2004-04-30 | Not classified | Other | Product sterility may be compromised due to the lack of package seal integrity | 951 boxes(6 probes/box) | 2005-06-13 |
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.