Anterior Capsulectomy Cystitome
FDA 510(k) K840659 · Sharpoint, Inc.
510(k) numberK840659
Submission
- Device name
- Anterior Capsulectomy Cystitome
- Applicant
- Sharpoint, Inc.
Walker, MI, US - Received
- February 15, 1984
- Decision date
- March 16, 1984
- 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 |
|---|---|---|
| K863595 | Coated Suture NeedleGAB · Traditional | 10/24/1986SE |
| K861947 | Surgical KnifeEMF · Traditional | 06/06/1986SE |
| K840764 | Ear KnivesJYO · Traditional | 05/21/1984SE |
| K840855 | Corneal Scleral LanceHNN · Traditional | 05/09/1984SE |
| K840660 | Posterior Capsulotomy CystitomeHNY · Traditional | 03/16/1984SE |
| K830522 | Stainless Steel Suture 316L · Traditional | 03/31/1983SE |
| K822112 | Ophthalmic KnifeHNN · Traditional | 08/10/1982SE |
| K821440 | V LanceHNN · Traditional | 06/14/1982SE |
Questions and answers
When was Anterior Capsulectomy Cystitome cleared by the FDA?
Anterior Capsulectomy Cystitome (K840659) received a 510(k) decision of Substantially Equivalent on March 16, 1984, 30 days after the submission was received.
What is the product code of K840659?
The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.