Surgitek Flat T-Span
FDA 510(k) K884746 · Medical Engineering Corp.
510(k) numberK884746
Submission
- Device name
- Surgitek Flat T-Span
- Applicant
- Medical Engineering Corp.
Racine, WI, US - Received
- November 14, 1988
- Decision date
- August 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCJ – Tissue Expander And Accessories
- Device class
- Unclassified
- Implant
- Yes
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| K211676 | Motiva Flora SmoothSilk Tissue ExpanderLCJ · Traditional | Motiva USA, LLC | 10/13/2023SE |
| K214124 | AlloX2 Pro Tissue ExpandersLCJ · Traditional | Sientra, Inc. | 06/08/2023SE |
| K221127 | Sientra, inc. PortfinderLCJ · Traditional | Sientra, Inc. | 05/10/2023SE |
| K180826 | Natrelle 133 Plus MICROCELL Tissue ExpanderLCJ · Traditional | Allergan | 12/21/2018SE |
| K182335 | CPX 4 Breast Tissue Expander with Smooth SurfaceLCJ · Special | Mentor Worldwide, LLC | 09/25/2018SE |
| K182054 | Natrelle 133S Tissue ExpanderLCJ · Special | Allergan | 08/29/2018SE |
More from Allergan
| 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 |
| 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 |
Questions and answers
When was Surgitek Flat T-Span cleared by the FDA?
Surgitek Flat T-Span (K884746) received a 510(k) decision of Substantially Equivalent on August 10, 1989, 269 days after the submission was received.
What is the product code of K884746?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.