Retractive Incision Micrometer (Rim) Guage
FDA 510(k) K882402 · Optical Center
510(k) numberK882402
Submission
- Device name
- Retractive Incision Micrometer (Rim) Guage
- Applicant
- Optical Center
Oxnard, CA, US - Received
- June 10, 1988
- Decision date
- August 22, 1988
- 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 |
| 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 |
| K863725 | Cataract Diamond KnifeHNN · Traditional | Medical Technology Development Corp. | 10/31/1986SE |
Questions and answers
When was Retractive Incision Micrometer (Rim) Guage cleared by the FDA?
Retractive Incision Micrometer (Rim) Guage (K882402) received a 510(k) decision of Substantially Equivalent on August 22, 1988, 73 days after the submission was received.
What is the product code of K882402?
The FDA product code is HNN – Knife, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.