Surgikek Penile Prosthesis Tail Extend
FDA 510(k) K832043 · Medical Engineering Corp.
510(k) numberK832043
Submission
- Device name
- Surgikek Penile Prosthesis Tail Extend
- Applicant
- Medical Engineering Corp.
Mchenry, IL, US - Received
- June 24, 1983
- Decision date
- October 20, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAE – Prosthesis, Penile
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.3630
- Specialty
- Gastroenterology, Urology
- Implant
- Yes
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| K040959 | Mentor Genesis Penile ProsthesisFAE · Traditional | Mentor Corp. | 10/29/2004SE |
| K963328 | Ams Ambicor Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 12/04/1996SE |
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| K951716 | Ams 650 Mallerable Peniel ProsthesisFAE · Traditional | American Medical Systems, Inc. | 07/06/1995SE |
| K920420 | Dura II Penile ProsthesisFAE · Traditional | Dacomed Corp. | 04/16/1992SE |
| K912935 | Ams Malleable 600 and 600M Penile ProsthesisFAE · Traditional | American Medical Systems, Inc. | 03/18/1992SE |
More from American Medical Systems, Inc.
| 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 |
Questions and answers
When was Surgikek Penile Prosthesis Tail Extend cleared by the FDA?
Surgikek Penile Prosthesis Tail Extend (K832043) received a 510(k) decision of Substantially Equivalent on October 20, 1983, 118 days after the submission was received.
What is the product code of K832043?
The FDA product code is FAE – Prosthesis, Penile, a Class II (moderate risk) device regulated under 21 CFR 876.3630.