Product code HQE— Ophthalmic
I/A HANDPIECE
- Classification name
- Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class 2
- Regulation
- 21 CFR 886.4150
- Advisory panel
- Ophthalmic
- Total cleared
- 149
- First cleared
- Most recent
Market context for product code HQE
FDA has cleared devices under product code HQE between 1977 and 2022, filed by 68 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2017
- 2016
- 2014
- 2012
- 2011
- 2003
- 2002
- 2001
- 1999
- 1998
- 1997
- 1996
- 1995
- 1994
Top applicants under product code HQE
Adverse events under product code HQE
product code HQE- Injury
- 156
- Malfunction
- 565
- Total
- 721
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 HQE
1–100 of 149- K212763 — UniVit HE, UniVit UHS
- K170183 — Cetus system, Cetus probe
- K153168 — Bi-Blade Vitrectomy Cutter
- K141065 — CONSTELLATION VISION SYSTEM
- K121675 — VERSAVIT
- K120170 — PROCARE PLUS VITRECTOMY SYSTEM
- K102222 — ULTIMATE VIT ENHAMCER (UVE)
- K033390 — COLIBRI DISPOSABLE VITRECTOMY CUTTER
- K030948 — VMATE MODEL VMM1000
- K023939 — VELOCITY ADVANTAGE
- K020911 — MID LABS AUTONOMOUS VIT ENHANCER (AVE)
- K010082 — D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
- K992943 — VIT ENHANCER
- K990292 — I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN
- K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM
- K980399 — PEREGRINE OPTIPORT VITRECTOMY PROBE MODEL PD500.20
- K980400 — PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10
- K980488 — STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
- K970670 — REUSABLE VITRECTOMY PROBE
- K970673 — DISPOSABLE VITRECTOMY PROBE
- K964743 — STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
- K961738 — VIT COMMANDER SYSTEM
- K960061 — STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
- K961078 — AUTOMATED VITRECTOMY DEVICE
- K954816 — STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
- K953575 — STORZ MVS-3201 VITRECTOMY PROBE PACK
- K953576 — STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
- K950852 — CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
- K950799 — PRO-VIT
- K946135 — INFINITECH ASPIRATING LASER PROBE
- K946181 — INFINITECH SOFT TIP FLUTE NEEDLE
- K934600 — MICRODRIVE
- K936302 — NIDEK MODEL VT-4000, MODIFICATION
- K940391 — PEREGRINE REVERSE CUTTING KNIFE LIGHT PIPE
- K940746 — VIT CUTTER MODEL 94
- K932669 — SUPRA-VIT(TM)
- K930842 — THE GRIESHABER SYST/AI TUBING SET AND CARTRIDGE
- K933907 — STORZ FIBEROPTIC PICK MANIPULATOR
- K932668 — OPHTHALMIC SURGICAL PNEUMATIC SCISSORS DRIVER
- K934204 — INTERTIP INFUSION SET
- K933984 — STORZ FIBEROPTIC REVERSE CUTTING KNIFE
- K933208 — BARE-FIBER ENDOILLUMINATOR
- K924353 — NIDEK MODEL VST-4000
- K924222 — MID LABS, INC. VIT MATE
- K924604 — STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
- K922355 — POLLY'S VITREOUS SCISSORS J-225-S
- K921758 — STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
- K921460 — STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
- K920718 — DISPOSABLE POSTERIOR MICROSCISSORS
- K920582 — 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
- K915745 — D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
- K913504 — STORZ MICRO CUTTER 25 GAUGE PACK
- K913261 — DWYER EYE SYSTEMS ASPIRATION UNIT
- K912384 — DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
- K914038 — POLLY'S CUTTER J-225
- K913837 — MICROSCIS(TM) INTROCULAR SCISSOR SYSTEM
- K914221 — KPE 220 TS, NONSTERILE
- K912253 — LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
- K911998 — MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
- K910973 — DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
- K904909 — I/A VITROPHAGE MODEL YPR 2001
- K895813 — GLAUCOMA MECHANICAL TREPHINE
- K896943 — SITE DISPOSABLE CUTTER AND ACCESSORIES
- K894248 — CONVERTER SYSTEM
- K896754 — I/A HANDPIECE
- K896305 — MULTI-USE I/A HANDPIECE
- K894278 — STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
- K890195 — JAMES SURGICAL SYSTEM J1000
- K891601 — POWER OPERATED AND CONTROLLED VITREOUS SCISSORS
- K884557 — ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
- K890622 — SURG-E-TROL SYSTEM I AND SYSTEM II
- K890300 — INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
- K890133 — OCULAR CONNECTION MACHINE(TM)
- K884556 — DREYER CURVED ENDOILLUMINATOR
- K890544 — SHAPIRO CUTTER
- K885196 — LASER INDIRECT OPHTHALMOSCOPE (LIO)
- K884043 — GRIESHABER MICRO LITE LIGHT PIPE 19 & 20 GAUGE
- K883926 — .2MM, .4MM, .5MM IRRIGATION AND ASPIRATION HAND.
- K883605 — MODIFIED REUSABLE SITE FIBER OPTIC CABLE
- K883975 — DISP. 20 GAUGE SITE FIBER OPTIC CABLE & ILLUMI.
- K881519 — VAC-G (GUILLOTINE VITRECTOR)
- K881520 — VAC (OSCILLATING VITRECTOR)
- K880943 — MICROLINE CAT #100
- K880929 — NIDEK CV-4000
- K881927 — PRISMA TECH 19 GAUGE DISPOSABLE EXTRUSION NEEDLES
- K880968 — MODEL 2001 PHACOEMULSIFIER ASPIRATOR
- K872312 — MODEL 3000 OPHTHALMIC SURGICAL SYSTEM
- K871871 — SERIES TEN THOUSAND OCUTOME
- K871375 — SITE PERISTALTIC MODULE SYSTEM
- K870775 — ENTRAVISION MODECO II VITREOUS CUTTING HANDPIECE
- K870068 — ASPIRATION REVERSAL CONTROL (ARC) MODULE
- K864035 — VES-10 INTRAOCULAR SCISSORS DRIVE
- K862188 — IRRIGATION & ASPIRATION/VITRECTOMY DEVICE
- K862943 — SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE
- K861380 — SERIES TEN THOUSAND MASTER
- K861565 — SERIES TEN THOUSAND COMPACT
- K862343 — VACUUM HANDLE MODEL I/A - 1
- K860891 — AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
- K860014 — SYSTEMS PLUS
- K834160 — VITREONIC PLUS
Data sourced from openFDA. This site is unofficial and independent of the FDA.