Mechanical Cystitome
FDA 510(k) K862709 · Rudolph Beaver, Inc.
510(k) numberK862709
Submission
- Device name
- Mechanical Cystitome
- Applicant
- Rudolph Beaver, Inc.
Waltham, MA, US - Received
- July 16, 1986
- Decision date
- August 1, 1986
- 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 |
|---|---|---|
| K883361 | Arthro-Trac(Tm)HRX · Traditional | 10/13/1988SE |
| K875030 | OCU-1HMX · Traditional | 05/03/1988SE |
| K860305 | Beaver Micro-Gem Gauge BlockHNN · Traditional | 02/12/1986SE |
| K852828 | Beaver R-K KnifeHNN · Traditional | 11/04/1985SN |
| K853129 | Beaver Multipurpose Sapphire KnifeHNN · Traditional | 08/06/1985SE |
Questions and answers
When was Mechanical Cystitome cleared by the FDA?
Mechanical Cystitome (K862709) received a 510(k) decision of Substantially Equivalent on August 1, 1986, 16 days after the submission was received.
What is the product code of K862709?
The FDA product code is HNY – Cystotome, a Class I (low risk) device regulated under 21 CFR 886.4350.