Surgitek Reconstruc-Nipple Prosthesis
FDA 510(k) K842748 · Medical Engineering Corp.
510(k) numberK842748
Submission
- Device name
- Surgitek Reconstruc-Nipple Prosthesis
- Applicant
- Medical Engineering Corp.
Mchenry, IL, US - Received
- July 13, 1984
- Decision date
- September 26, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
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|---|---|---|
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| 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 |
| K832043 | Surgikek Penile Prosthesis Tail ExtendFAE · Traditional | 10/20/1983SE |
Questions and answers
When was Surgitek Reconstruc-Nipple Prosthesis cleared by the FDA?
Surgitek Reconstruc-Nipple Prosthesis (K842748) received a 510(k) decision of Substantially Equivalent on September 26, 1984, 75 days after the submission was received.