Surgitek(R) External Fill Port
FDA 510(k) K894495 · Surgitek
510(k) numberK894495
Submission
- Device name
- Surgitek(R) External Fill Port
- Applicant
- Surgitek
Racine, WI, US - Received
- July 19, 1989
- Decision date
- January 17, 1990
- 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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| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue ExpanderLCJ · Special | Mentor Worldwide, LLC | 08/02/2024SE |
| 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 |
|---|---|---|
| K946296 | Quadra-Coil Ureteral StentFAD · Traditional | 03/06/1995SE |
| K944391 | OM-4 (Tenative) Urodynamic Measruement SystemFEN · Traditional | 02/07/1995SE |
| K943491 | Right Angle Urologic Laser FiberGEX · Traditional | 08/05/1994SE |
| K941952 | Surgitek InfuserFAD · Traditional | 05/24/1994SE |
| K933261 | Grasping ForcepsFGO · Traditional | 01/11/1994SE |
| K933260 | Helical Stone/Flatwire Stone BasketsFFL · Traditional | 01/11/1994SE |
| K930733 | Ureteral StentFAD · Traditional | 07/23/1993SE |
| K930483 | Ureteral CatheterEYB · Traditional | 07/16/1993SESK |
| K926344 | Hydrophilic Coated GuidewireKNY · Traditional | 03/05/1993SE |
| K920451 | Endotek Ultra SystemFAP · Traditional | 09/17/1992SE |
Questions and answers
When was Surgitek(R) External Fill Port cleared by the FDA?
Surgitek(R) External Fill Port (K894495) received a 510(k) decision of Substantially Equivalent on January 17, 1990, 182 days after the submission was received.
What is the product code of K894495?
The FDA product code is LCJ – Tissue Expander And Accessories, a Unclassified device.