Cystotomes
FDA 510(k) K790244 · Visitec Co.
510(k) numberK790244
Submission
- Device name
- Cystotomes
- Applicant
- Visitec Co.
Mchenry, IL, US - Received
- December 29, 1978
- Decision date
- February 12, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNY – Cystotome
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNY
| 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 |
More from Noetix, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953394 | Visitec Collar Button Catheter {Griffiths}LZU · Traditional | 10/12/1995SE |
| K945114 | Visitec Scleral PlugLXP · Traditional | 02/23/1995SE |
| K945738 | Visiflex Ophthalmic Surgical Incise DrapeHMT · Traditional | 02/14/1995SE |
| K945172 | Visitec Silicone Retinal Implants/ExplantsHQX · Traditional | 01/17/1995SE |
| K942234 | Visitec Precise-PointGAP · Traditional | 07/12/1994SE |
| K934269 | Fiberoptic Illuminated InstrumentsHJM · Traditional | 05/17/1994SE |
| K940210 | Visitec Eye PadEFQ · Traditional | 03/07/1994SE |
| K933872 | Visi-Spear Eye SpongeHOZ · Traditional | 12/27/1993SE |
| K923972 | Ophthalmic Fluid Distribution SetsFPK · Traditional | 11/04/1992SE |
| K922530 | Visitec Microsurgical SutureGAR · Traditional | 10/20/1992SE |
Questions and answers
When was Cystotomes cleared by the FDA?
Cystotomes (K790244) received a 510(k) decision of Substantially Equivalent on February 12, 1979, 45 days after the submission was received.
What is the product code of K790244?
The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.