Gore-Tex Sam Facial Implant
FDA 510(k) K946267 · W. L. Gore & Associates, Inc.
510(k) numberK946267
Submission
- Device name
- Gore-Tex Sam Facial Implant
- Applicant
- W. L. Gore & Associates, Inc.
Flagstaff, AZ, US - Received
- December 23, 1994
- Decision date
- March 22, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FWP – Prosthesis, Chin, Internal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3550
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| K232593 | FITme Customized Silicone ImplantFWP · Traditional | Keosan Trading Co. | 11/22/2023SE |
| K200610 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 12/23/2020SE |
| K191130 | Customized Contour ImplantFWP · Traditional | Implantech Associates, Inc. | 08/23/2019SE |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant KitFWP · Special | Stryker Leibinger GmbH & Co KG | 08/15/2019SE |
| K153508 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 02/05/2016SE |
| K152463 | SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial ImplantFWP · Traditional | Poriferous, LLC | 01/20/2016SE |
| K143173 | Stryker CMF MEDPOR Customized ImplantFWP · Traditional | Stryker | 03/23/2015SE |
| K141027 | 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar…FWP · Traditional | Implantech Associates, Inc. | 07/10/2014SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | Howmedica Osteonics Corp. | 11/01/2012SE |
More from Howmedica Osteonics Corp.
| 510(k) | Device | Decision |
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| K250410 | GORE® Tri-Lobe Balloon CatheterDQY · Traditional | 06/02/2025SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 03/01/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | 06/23/2023SE |
| K191773 | GORE BIO-A Tissue ReinforcementOWT · Special | 07/31/2019SE |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementOXC · Special | 08/17/2018SE |
| K173333 | GORE ENFORM BiomaterialOXF · Traditional | 04/05/2018SE |
| K163576 | GORE SYNECOR Preperitoneal BiomaterialFTL · Traditional | 05/11/2017SE |
| K170740 | GORE VIABIL Short Wire Biliary EndoprosthesisFGE · Traditional | 05/08/2017SESU |
Questions and answers
When was Gore-Tex Sam Facial Implant cleared by the FDA?
Gore-Tex Sam Facial Implant (K946267) received a 510(k) decision of Substantially Equivalent on March 22, 1995, 89 days after the submission was received.
What is the product code of K946267?
The FDA product code is FWP – Prosthesis, Chin, Internal, a Class II (moderate risk) device regulated under 21 CFR 878.3550.