Prisma Disposable Blunt Irrigating Cystotome
FDA 510(k) K875001 · Advanced Surgical Products, Inc.
510(k) numberK875001
Submission
- Device name
- Prisma Disposable Blunt Irrigating Cystotome
- Applicant
- Advanced Surgical Products, Inc.
Chesterfield, MO, US - Received
- December 4, 1987
- Decision date
- April 13, 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 |
| K880345 | Cystotomes/KnifesHNY · Traditional | Myocure, Inc. | 05/03/1988SE |
| 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 |
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| K895800 | Advanced Surgical Solid State Bipolar CoagulatorHQR · Traditional | 01/22/1990SE |
| K896754 | I/A HandpieceHQE · Traditional | 01/11/1990SE |
| K896305 | Multi-Use I/A HandpieceHQE · Traditional | 12/18/1989SE |
| K884557 | Advanced Surgical Products Scissors HandpieceHQE · Traditional | 05/12/1989SE |
| K884556 | Dreyer Curved EndoilluminatorHQE · Traditional | 02/28/1989SE |
| K890398 | Ryan-Style Directed Infusion ManipulatorHBI · Traditional | 02/17/1989SE |
| K884347 | Modified Disposable Coaxial Bipolar PenGXI · Traditional | 12/27/1988SE |
| K883858 | Fiberoptic Sharp Integral Pick LightpipeHBI · Traditional | 09/29/1988SE |
| K883857 | Fiberoptic Wire Pick LightpipeHBI · Traditional | 09/29/1988SE |
Questions and answers
When was Prisma Disposable Blunt Irrigating Cystotome cleared by the FDA?
Prisma Disposable Blunt Irrigating Cystotome (K875001) received a 510(k) decision of Substantially Equivalent on April 13, 1988, 131 days after the submission was received.
What is the product code of K875001?
The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.