HQE · Class II · 21 CFR 886.4150

FDA Product Code HQE: Instrument, Vitreous Aspiration And Cutting, Ac-powered

Leading manufacturers include Storz Instrument Co., CooperVision, Inc. and Advanced Surgical Products, Inc..

149
Total
149
Cleared
114d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Instrument, Vitreous Aspiration And Cutting, Ac-powered Devices (Product Code HQE)

149 devices
1–24 of 149
Cleared Aug 10, 2022
UniVit HE, UniVit UHS
K212763
Visioncare Devices, LLC
Ophthalmic · 344d
Cleared Mar 23, 1998
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM
K980488
Storz Instrument Co.
Ophthalmic · 42d
Cleared Feb 03, 1997
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR
K964743
Storz Instrument Co.
Ophthalmic · 69d
Cleared Sep 18, 1996
STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
K960061
Storz Instrument Co.
Ophthalmic · 258d
Cleared Mar 04, 1996
STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX
K954816
Storz Instrument Co.
Ophthalmic · 136d
Cleared Sep 14, 1995
STORZ MVS-3201 VITRECTOMY PROBE PACK
K953575
Storz Instrument Co.
Ophthalmic · 45d
Cleared Sep 14, 1995
STORZ DP4505 VITREOUS MEMBRANE DISSECTOR
K953576
Storz Instrument Co.
Ophthalmic · 45d
Cleared Jul 15, 1994
NIDEK MODEL VT-4000, MODIFICATION
K936302
Nidek, Inc.
Ophthalmic · 198d
Cleared Mar 07, 1994
STORZ FIBEROPTIC PICK MANIPULATOR
K933907
Storz Instrument Co.
Ophthalmic · 208d
Cleared Jan 25, 1994
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
K933984
Storz Instrument Co.
Ophthalmic · 162d
Cleared Mar 29, 1993
NIDEK MODEL VST-4000
K924353
Nidek, Inc.
Ophthalmic · 213d
Cleared Nov 27, 1992
STORZ REUS 20/25 GAUGE VITRE CUT W/REUS HAND/DRIV
K924604
Storz Instrument Co.
Ophthalmic · 77d
Cleared Jul 16, 1992
STORZ PROTEGE OPTHALMIC MICROSURGICAL SYSTEM
K921758
Storz Instrument Co.
Ophthalmic · 94d
Cleared Jul 02, 1992
STORZ PREMIERE/PREMIERE MICROVIT MICROSURG SYSTEMS
K921460
Storz Instrument Co.
Ophthalmic · 97d
Cleared May 18, 1992
DISPOSABLE POSTERIOR MICROSCISSORS
K920718
Storz Instrument Co.
Ophthalmic · 90d
Cleared Mar 13, 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K915745
Storz Instrument Co.
Ophthalmic · 81d
Cleared Dec 24, 1991
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE
K912384
Nidek, Inc.
Ophthalmic · 210d
Cleared Aug 07, 1991
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
K912253
Ocular Instruments, Inc.
Ophthalmic · 78d
Cleared Jan 11, 1990
I/A HANDPIECE
K896754
Advanced Surgical Products, Inc.
Ophthalmic · 42d
Cleared Dec 18, 1989
MULTI-USE I/A HANDPIECE
K896305
Advanced Surgical Products, Inc.
Ophthalmic · 49d
Cleared Aug 11, 1989
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K894278
Storz Instrument Co.
Ophthalmic · 49d
Cleared May 12, 1989
ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
K884557
Advanced Surgical Products, Inc.
Ophthalmic · 193d
Cleared Apr 17, 1989
INTERCASSETTE, INTERKIT, UNIVERSAL PAK & CASSETTE
K890300
CooperVision, Inc.
Ophthalmic · 88d
Cleared Feb 28, 1989
DREYER CURVED ENDOILLUMINATOR
K884556
Advanced Surgical Products, Inc.
Ophthalmic · 120d

About Product Code HQE - Regulatory Context

510(k) Submission Activity

149 total 510(k) submissions under product code HQE since 1977, with 149 receiving FDA clearance (average review time: 114 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.