Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens Manipulators
FDA 510(k) K961524 · Sterilab, Inc.
510(k) numberK961524
Submission
- Device name
- Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens Manipulators
- Applicant
- Sterilab, Inc.
Carlsbad, CA, US - Received
- April 22, 1996
- Decision date
- May 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
Questions and answers
When was Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens Manipulators cleared by the FDA?
Sterilab Cannulas, Sterilab Cystotmes, Sterilab Needles and Sterilab Lens Manipulators (K961524) received a 510(k) decision of Substantially Equivalent on May 16, 1996, 24 days after the submission was received.
What is the product code of K961524?
The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.