Cystotome
FDA product code HNY · Class I (low risk) · 21 CFR 886.4350 · Ophthalmic
20510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K961524 | Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens ManipulatorsHNY · Traditional | Sterilab, Inc. | 05/16/1996SE |
| K880345 | Cystotomes/KnifesHNY · Traditional | Myocure, Inc. | 05/03/1988SE |
| K875001 | Prisma Disposable Blunt Irrigating CystotomeHNY · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874997 | Prisma Disposable Straight Irrigating CystotomeHNY · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874993 | Prisma Disposable Sharp Irrigating CystotomeHNY · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874983 | Prisma Disposable Angled Irrigating CystotomeHNY · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874976 | Prisma Dispos. Double Sharp Irrigating CystotomeHNY · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874975 | Prisma Disposable Sharp Angled Irrigat. CystotomeHNY · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K873163 | Van Dellen Irrigating CystotomeHNY · Traditional | Van Dellen, Ltd. | 09/04/1987SE |
| K871365 | Capsulectomer CystotomeHNY · Traditional | Noetix, Inc. | 04/16/1987SE |
| K870439 | Look Irrigating CystotomesHNY · Traditional | Look, Inc. | 02/20/1987SE |
| K862709 | Mechanical CystitomeHNY · Traditional | Rudolph Beaver, Inc. | 08/01/1986SE |
| K852934 | Precision - Cosmet Capsule CoupeurHNY · Traditional | Precision-Cosmet Co., Inc. | 08/08/1985SE |
| K841101 | Clayman-Parel Capsule CoupeurHNY · Traditional | Miami Eye Technology, Inc. | 05/16/1984SE |
| K840475 | Cystotome, 140-SHNY · Traditional | Cilco, Inc. | 04/05/1984SE |
| K840660 | Posterior Capsulotomy CystitomeHNY · Traditional | Sharpoint, Inc. | 03/16/1984SE |
| K840659 | Anterior Capsulectomy CystitomeHNY · Traditional | Sharpoint, Inc. | 03/16/1984SE |
| K831916 | Disposable CystotomeHNY · Traditional | CooperVision, Inc. | 07/12/1983SE |
| K830040 | Disposable CystotomeHNY · Traditional | Contemporary Surgical Systems, Inc. | 02/07/1983SE |
| K790244 | CystotomesHNY · Traditional | Visitec Co. | 02/12/1979SE |