Cystotomes/Knifes
FDA 510(k) K880345 · Myocure, Inc.
510(k) numberK880345
Submission
- Device name
- Cystotomes/Knifes
- Applicant
- Myocure, Inc.
Glendale, CA, US - Received
- January 26, 1988
- Decision date
- May 3, 1988
- 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 |
| 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 |
More from Look, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880347 | Anesthesia/Retrobulbar NeedlesHMX · Traditional | 05/03/1988SE |
| K880346 | CannulasHMX · Traditional | 05/03/1988SE |
| K874057 | Ophthalmic Tip & Blade ScalpelsHNN · Traditional | 12/23/1987SE |
| K874056 | Ophthalmic Disposable BladesHNN · Traditional | 12/22/1987SE |
| K873385 | Ophthalmic Phaco-BladeHNN · Traditional | 09/21/1987SE |
| K864371 | Surgical Skin MarkerFZZ · Traditional | 11/17/1986SE |
| K863666 | The Saver Kit · Traditional | 10/20/1986SE |
| K863663 | Ophthalmic Surgical Ocular MarkersHMR · Traditional | 10/20/1986SE |
| K863662 | Ophthalmic Surgical Drape · Traditional | 10/20/1986SE |
| K863665 | The UltimateHNN · Traditional | 09/25/1986SE |
Questions and answers
When was Cystotomes/Knifes cleared by the FDA?
Cystotomes/Knifes (K880345) received a 510(k) decision of Substantially Equivalent on May 3, 1988, 98 days after the submission was received.
What is the product code of K880345?
The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.