Versablade
FDA 510(k) K852706 · Alphamedix, Inc.
510(k) numberK852706
Submission
- Device name
- Versablade
- Applicant
- Alphamedix, Inc.
Cupertino, CA, US - Received
- June 26, 1985
- Decision date
- November 4, 1985
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- HNN – Knife, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
Other 510(k)s with product code HNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110166 | Clearcut S Safety KnifeHNN · Abbreviated | Alcon Research, Ltd. | 05/20/2011SE |
| K922378 | Ophthalmic KnifeHNN · Traditional | Microptics Development Laboratory | 12/10/1992SE |
| K882402 | Retractive Incision Micrometer (Rim) GuageHNN · Traditional | Optical Center | 08/22/1988SE |
| K881669 | Mvr/Stiletto Blade 20GA. - P/N 1900HNN · Traditional | Advanced Surgical Products, Inc. | 05/13/1988SE |
| K874979 | Prisma Disposable Mvr/Stiletto BladeHNN · Traditional | Advanced Surgical Products, Inc. | 04/13/1988SE |
| K874057 | Ophthalmic Tip & Blade ScalpelsHNN · Traditional | Myocure, Inc. | 12/23/1987SE |
| K874056 | Ophthalmic Disposable BladesHNN · Traditional | Myocure, Inc. | 12/22/1987SE |
| K873385 | Ophthalmic Phaco-BladeHNN · Traditional | Myocure, Inc. | 09/21/1987SE |
| K871285 | Knife, OphthalmicHNN · Traditional | Trueline Instruments, Inc. | 04/27/1987SE |
| K864290 | Rk-M & Rk-Dk Diamond Knives with Measuring GaugeHNN · Traditional | Keeler Instruments, Inc. | 12/15/1986SE |
More from Keeler Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K852633 | VersabladeHNN · Traditional | 11/04/1985SN |
| K851272 | VersaphageHQE · Traditional | 07/05/1985SE |
| K830812 | Alphamedix I/A Hand-Piece, 500-001HQC · Traditional | 06/08/1983SE |
| K830703 | GlomarkFZZ · Traditional | 04/28/1983SE |
| K820363 | Disposable Surgical GarmentsFYA · Traditional | 03/08/1982SE |
| K820008 | Versatome IHQE · Traditional | 02/22/1982SE |
Questions and answers
When was Versablade cleared by the FDA?
Versablade (K852706) received a 510(k) decision of Substantially Equivalent for Some Indications on November 4, 1985, 131 days after the submission was received.
What is the product code of K852706?
The FDA product code is HNN – Knife, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.