Medical Engineering Corp.
Medical device manufacturer in Racine, WI.
28510(k) clearances
0PMA approvals
0recalls
Device types
- FAD Stent, Ureteral 5
- LJE Catheter, Nephrostomy 3
- FGB Ureteroscope And Accessories, Flexible/Rigid 3
- DWS Instruments, Surgical, Cardiovascular 2
- FRL Fiber, Medical, Absorbent 2
- FAE Prosthesis, Penile 2
- LCJ Tissue Expander And Accessories 2
- GCY Apparatus, Suction, Single Patient Use… 1
- KDC Instrument, Surgical, Disposable 1
- BTO Tube, Tracheostomy (W/Wo Connector) 1
- BTR Tube, Tracheal (W/Wo Connector) 1
- FAP Cystometric Gas (Carbon-Dioxide) On… 1
- FFG Device, Urine Flow Rate Measuring… 1
- FEN Device, Cystometric, Hydraulic 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K934141 | Stand Alone CystometrogramFEN · Traditional | 11/18/1993SE |
| K905289 | Surgitek(R) Lubri-Flex(Tm) Ureteral StentFAD · Traditional | 03/13/1991SE |
| K903448 | Surgitek Tex-Span Textured Tissue ExpanderLCJ · Traditional | 01/14/1991SE |
| K902773 | Surgitek(R) Flexible Ureteroscopy Intro/Sheath SetFGB · Traditional | 07/16/1990SE |
| K884746 | Surgitek Flat T-SpanLCJ · Traditional | 08/10/1989SE |
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | 02/08/1989SE |
| K881736 | Surgitek CO2 Delivery SystemFAP · Traditional | 08/11/1988SE |
| K880802 | Surgitek Articulating Ureteroscope Model SU-11FGB · Traditional | 05/26/1988SE |
| K880801 | Surgitek Flexible Ureteroscope SU-7 & SU-9FGB · Traditional | 05/26/1988SE |
| K842748 | Surgitek Reconstruc-Nipple Prosthesis · Traditional | 09/26/1984SE |
| K832043 | Surgikek Penile Prosthesis Tail ExtendFAE · Traditional | 10/20/1983SE |
| K833008 | Percutaneous Nephrostomy CatheterLJE · Traditional | 10/19/1983SE |
| K831857 | Surgitek Percutaneous Arnegrade SilitekFAD · Traditional | 08/11/1983SE |
| K830884 | Surgiteks Percutaneous Antegrade All -FAD · Traditional | 05/09/1983SE |
| K823757 | Surgitek Endotracheal Tube, Laser ResisBTR · Traditional | 04/28/1983SE |
| K830917 | Surgitek Sizer for Penile ProsthesisFAE · Traditional | 04/12/1983SE |
| K830226 | Surgitek Percutaneous Nephrostomy CathLJE · Traditional | 02/09/1983SE |
| K822295 | Surgi Tek's Dispos. Inner Cannula forBTO · Traditional | 08/20/1982SE |
| K821776 | Surgitek Percutaneous Nephrost. StentLJE · Traditional | 08/10/1982SE |
| K803156 | Surgitek Medi-LoopsKDC · Traditional | 01/15/1981SE |
| K800331 | Surgitek Foerster Face Lift DrainGCY · Traditional | 03/05/1980SE |
| K800109 | Surgitek Urinary Diversion StentFAD · Traditional | 02/26/1980SE |
| K800249 | Surgitek Foerster Mammary BandageFRL · Traditional | 02/19/1980SE |
| K800248 | Surgitek Foerster Face Lift BandageFRL · Traditional | 02/19/1980SE |
| K790245 | Standard Pectoralis Muscle Implant · Traditional | 04/04/1979SE |
| K781641 | Surgitek Double J Ureterol StentFAD · Traditional | 12/07/1978SE |
| K781336 | Surgitek Disposable Flo-ResterDWS · Traditional | 10/10/1978SE |
| K761328 | Anastomasis OccluderDWS · Traditional | 02/01/1977SE |