Product code HNN— Ophthalmic
MICROSURGICAL KNIFE
- Classification name
- Knife, Ophthalmic
- Device class
- Class 1
- Regulation
- 21 CFR 886.4350
- Advisory panel
- Ophthalmic
- Total cleared
- 54
- First cleared
- Most recent
Market context for product code HNN
FDA has cleared devices under product code HNN between 1976 and 2011, filed by 30 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2011
- 1992
- 1988
- 1987
- 1986
- 1985
- 1984
- 1983
- 1982
- 1981
- 1979
- 1978
- 1976
Top applicants under product code HNN
Adverse events under product code HNN
product code HNN- Injury
- 183
- Malfunction
- 4,106
- Total
- 4,289
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HNN
- K110166 — CLEARCUT S SAFETY KNIFE
- K922378 — OPHTHALMIC KNIFE
- K882402 — RETRACTIVE INCISION MICROMETER (RIM) GUAGE
- K881669 — MVR/STILETTO BLADE 20GA. - P/N 1900
- K874979 — PRISMA DISPOSABLE MVR/STILETTO BLADE
- K874057 — OPHTHALMIC TIP & BLADE SCALPELS
- K874056 — OPHTHALMIC DISPOSABLE BLADES
- K873385 — OPHTHALMIC PHACO-BLADE
- K871285 — KNIFE, OPHTHALMIC
- K864290 — RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
- K863725 — CATARACT DIAMOND KNIFE
- K863665 — THE ULTIMATE
- K861744 — SAPPHIRE KNIFE BLADE
- K861748 — RUBY & SAPPHIRE BLADE HOLDER
- K861491 — ROPHAE DIAMOND KNIFE
- K861732 — STORZ E9050 & E9055 DIAMOND KNIVES
- K861334 — CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE
- K860852 — SAPPHIRE BLADE SURGICAL KNIFE
- K855050 — STORZ E9040 & E9046 DIAMOND KNIVES
- K860332 — DIAMOND BLADE MICROMETER KNIFE
- K860305 — BEAVER MICRO-GEM GAUGE BLOCK
- K860331 — DISPOSABLE SURGICAL KNIFE
- K852633 — VERSABLADE
- K852706 — VERSABLADE
- K852828 — BEAVER R-K KNIFE
- K853063 — SMARTKNIFE SYSTEM
- K853403 — STORZ DIAMOND KNIFE
- K853598 — OPHTHALMIC KNIFE W/REMOVALE DEPTH GUIDE
- K853499 — MICRON-SCOPE
- K853129 — BEAVER MULTIPURPOSE SAPPHIRE KNIFE
- K851790 — 37-200 TO 37-246 VARIOUS OPHTHALMOLOGY SCALPELS/KN
- K842647 — CATARACT TRAY
- K850049 — KATENA MICROMETER KNIFE W/XTAL BLADE OF CRYSTAL SA
- K844553 — MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE
- K843447 — CILCO DIAMOND KNIFE
- K841951 — MICROSURGICAL KNIFE
- K840855 — CORNEAL SCLERAL LANCE
- K834546 — SURGICAL KNIFE
- K832844 — RUBY KNIVES FOR OPHTH. SURGERY
- K831975 — LEADING EDGE OPHTHALMIC KNIFE
- K831266 — MICROSURGICAL KNIFE
- K830366 — DIAMOND KNIFE
- K822112 — OPHTHALMIC KNIFE
- K821440 — V LANCE
- K820618 — MICROSURGERY KNIFE
- K812918 — PILLING K KNIFE
- K812620 — ADJUSTABLE MICROSURGICAL KNIFE
- K812450 — KOI DIAMOND KNIFE
- K791980 — TOME'S #'S 1221,1222,1223,1314,6640,6642
- K791981 — SWAN KNIFE NEEDLE 1.5MM CAT # 1170
- K781465 — MICROSURGICAL KNIVES, 20, 30, 45
- K760186 — DISSECTOR, TROUTMAN CORNEAL
- K760187 — KNIFE, TROUTMAN CORNEAL SMALL
- K760191 — KNIFE, TROUTMAN CORNEAL LARGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.