Rk-M & Rk-Dk Diamond Knives with Measuring Gauge
FDA 510(k) K864290 · Keeler Instruments, Inc.
510(k) numberK864290
Submission
- Device name
- Rk-M & Rk-Dk Diamond Knives with Measuring Gauge
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- October 31, 1986
- Decision date
- December 15, 1986
- Decision
- Substantially Equivalent (SESE)
- 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 |
| K863725 | Cataract Diamond KnifeHNN · Traditional | Medical Technology Development Corp. | 10/31/1986SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | 12/08/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K100500 | PSL Classic Slit LampHJO · Traditional | 03/09/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
Questions and answers
When was Rk-M & Rk-Dk Diamond Knives with Measuring Gauge cleared by the FDA?
Rk-M & Rk-Dk Diamond Knives with Measuring Gauge (K864290) received a 510(k) decision of Substantially Equivalent on December 15, 1986, 45 days after the submission was received.
What is the product code of K864290?
The FDA product code is HNN – Knife, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.