HNN — Knife, Ophthalmic Class I
FDA product code HNN covers "Knife, Ophthalmic", a Class I medical device regulated under 21 CFR 886.4350. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HNN
- Device Class
- Class I
- Regulation Number
- 886.4350
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110166 | alcon research | CLEARCUT S SAFETY KNIFE | May 20, 2011 |
| K922378 | microptics development laboratory | OPHTHALMIC KNIFE | December 10, 1992 |
| K882402 | optical center | RETRACTIVE INCISION MICROMETER (RIM) GUAGE | August 22, 1988 |
| K881669 | advanced surgical products | MVR/STILETTO BLADE 20GA. - P/N 1900 | May 13, 1988 |
| K874979 | advanced surgical products | PRISMA DISPOSABLE MVR/STILETTO BLADE | April 13, 1988 |
| K874057 | myocure | OPHTHALMIC TIP & BLADE SCALPELS | December 23, 1987 |
| K874056 | myocure | OPHTHALMIC DISPOSABLE BLADES | December 22, 1987 |
| K873385 | myocure | OPHTHALMIC PHACO-BLADE | September 21, 1987 |
| K871285 | trueline instruments | KNIFE, OPHTHALMIC | April 27, 1987 |
| K864290 | keeler instruments | RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE | December 15, 1986 |
| K863725 | medical technology development | CATARACT DIAMOND KNIFE | October 31, 1986 |
| K863665 | myocure | THE ULTIMATE | September 25, 1986 |
| K861744 | keeler instruments | SAPPHIRE KNIFE BLADE | June 9, 1986 |
| K861748 | keeler instruments | RUBY & SAPPHIRE BLADE HOLDER | June 2, 1986 |
| K861732 | storz instrument | STORZ E9050 & E9055 DIAMOND KNIVES | May 28, 1986 |
| K861491 | rophae lens co | ROPHAE DIAMOND KNIFE | May 28, 1986 |
| K861334 | cilco | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | May 2, 1986 |
| K860852 | med-tech develoment | SAPPHIRE BLADE SURGICAL KNIFE | March 28, 1986 |
| K855050 | storz instrument | STORZ E9040 & E9046 DIAMOND KNIVES | March 5, 1986 |
| K860332 | med-tech develoment | DIAMOND BLADE MICROMETER KNIFE | February 13, 1986 |