Stylet, Surgical, General & Plastic Surgery
FDA product code GAH · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
7510(k) clearances
0PMA approvals
3recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110355 | Venx RevolutionGAH · Traditional | Venx, LLC | 04/22/2011SE |
| K000932 | Arachnophlebectomy NeedleGAH · Traditional | Advanced Medical Products, Inc. | 05/17/2000SE |
| K970306 | Markman Template SystemGAH · Traditional | Barry Markman, M.D. | 11/20/1997SE |
| K972918 | Rapid Fire Hair Implanter CarouselGAH · Traditional | Apex Medical Products, LLC | 10/27/1997SE |
| K972521 | Navigator (Stylet) 2006GAH · Traditional | Sil-Med Corp. | 10/01/1997SE |
| K952737 | Calvitron Hair Transplant SystemGAH · Traditional | Medicamat S.A. | 10/03/1995SE |
| K770970 | Hair Transplant Punch, MultiplhGAH · Traditional | Padgett Instruments, Inc. | 10/27/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1780-2021 Class II | Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the…single use devices labeled as sterile may not have been adequately sterilized | Clinical Laserthermia Systems AB | 04/01/2021Terminated |
| Z-0323-2017 Class II | Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase…Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and… | Medtronic Navigation, Inc. | 09/01/2016Terminated |
| Z-0322-2017 Class II | Visualase Visualization Stylets PN 020-2301. The individual components within the…Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and… | Medtronic Navigation, Inc. | 09/01/2016Terminated |