Van Dellen Irrigating Cystotome
FDA 510(k) K873163 · Van Dellen, Ltd.
510(k) numberK873163
Submission
- Device name
- Van Dellen Irrigating Cystotome
- Applicant
- Van Dellen, Ltd.
Tucson, AZ, US - Received
- August 11, 1987
- Decision date
- September 4, 1987
- 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 |
| 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 |
|---|---|---|
| K873465 | Van Dellen Bacteria FilterFPK · Traditional | 01/20/1988SE |
| K873464 | Van Dellen CannulaJOL · Traditional | 11/23/1987SE |
| K873463 | Van Dellen Aspirating TubingBYY · Traditional | 11/23/1987SE |
| K873462 | Van Dellen AspiratorBTA · Traditional | 09/25/1987SE |
| K873164 | Van Dellen Healon CannulaHMX · Traditional | 09/04/1987SE |
| K873162 | Van Dellen Retrobulbar NeedleHMX · Traditional | 09/04/1987SE |
Questions and answers
When was Van Dellen Irrigating Cystotome cleared by the FDA?
Van Dellen Irrigating Cystotome (K873163) received a 510(k) decision of Substantially Equivalent on September 4, 1987, 24 days after the submission was received.
What is the product code of K873163?
The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.