510(k) K062475 ยท FFK Lithotriptor, Electro-Hydraulic
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
| Applicant | The Laryngeal Mask Co., Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, May 9, 2007 |
| Received | Aug 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2018 | Cook Inc. StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044 Terminated |
FFK | None listed |
| Jan 31, 2018 | Cook Inc. StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993 Terminated |
FFK | None listed |
| Jan 31, 2018 | Cook Inc. StoneBreaker Exhaust Line, Catalog number: SBA-EL; GPN: G52600; UDI: (01)00827002526006 Terminated |
FFK | None listed |
| Jan 31, 2018 | Cook Inc. StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013 Terminated |
FFK | None listed |
| Jan 31, 2018 | Cook Inc. StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020 Terminated |
FFK | None listed |
| Jan 31, 2018 | Cook Inc. StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034 Terminated |
FFK | None listed |
| Jan 31, 2018 | Cook Inc. StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605;
SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608 Terminated |
FFK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.