Panels › Gastroenterology, Urology › Product code FFK · Class 2
Lithotriptor, Electro-Hydraulic
Regulation 876.4480
0510(k)s in 12 months (61 all time)
0recalls in 12 months (22 all time)
22recalls that name a 510(k)
Top companies in FFK
| Company | 510(k)s | Recalls |
|---|---|---|
| Northgate Technologies, Inc. | 11 | 6 |
| Cook Inc. | 0 | 7 |
| Cybersonics, Inc. | 5 | 0 |
| Northgate Research, Inc. | 5 | 0 |
| ACMI CORPORATION | 0 | 4 |
| Electro Medical Systems SA | 4 | 0 |
| Richard Wolf Medical Instruments Corp. | 4 | 0 |
| Boston Scientific Corp | 2 | 1 |
| E.M.S Electro Medical Systems S.A | 2 | 1 |
| Med-Sonics Corp. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 1989 | K883189 | MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS KARL STORZ Endoscopy-America, Inc. | FFK |
| Jun 17, 1988 | K880503 | MDL-1 LASERTRIPTER Candela Laser Corp. | FFK |
| Feb 10, 1987 | K864904 | 3F ELECTRODE Northgate Research, Inc. | FFK |
| Dec 3, 1986 | K863642 | CANDELA MODEL MDL-1 LASER LITHOTRIPTOR Candela Corp. | FFK |
| Aug 21, 1985 | K852874 | 5F ELECTRODE(LITHOTRIPTOR) Northgate Research, Inc. | FFK |
| May 25, 1984 | K834228 | LITHOTRIPTOR ELECTRODE 4.5F Monaghan Medical Corp. | FFK |
| Nov 28, 1983 | K832566 | COAXIAL ELECTRODE #300A K-Med, Inc. | FFK |
| Feb 9, 1983 | K830086 | 4.5 F LITHOTRIPTOR ELECTRODE Monaghan Medical Corp. | FFK |
| Sep 28, 1982 | K822585 | LITHOTRIPTOR ELECTRODE 4.5F Monaghan Medical Corp. | FFK |
| Sep 21, 1982 | K822644 | RIWOLITH 2135 R. Wolf Medical Instruments Corp. | FFK |
| Nov 10, 1980 | K802322 | MODEL SD-1 DISINTEGRATOR Northgate Research, Inc. | FFK |
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