510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HQEClass II

Instrument, Vitreous Aspiration And Cutting, Ac-Powered

21 CFR 886.4150 / Ophthalmic
FDA source (opens on fda.gov)

HQE is the FDA product code for Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a class II device type, regulated under 21 CFR 886.4150. As of , FDA records hold 149 510(k) clearances under this code, the most recent dated , and 37 recalls.

Classification record

Product code
HQE
Device name
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
149
Ingested recalls
37

Clearances, product code HQE

By decision year
149 clearances under product code HQE with a decision year between 1977 and 2022, 1984 the highest year at 13.
Show the numbers
510(k) clearances under FDA product code HQE by decision year
YearClearances
19771
19781
19791
19802
19828
19836
198413
198513
198613
19875
198810
198911
19904
19918
19929
19933
199410
19956
19964
19973
19983
19993
20011
20021
20033
20111
20122
20141
20161
20171
20221

Applicants with the most clearances

Product code HQE
Applicants holding the most 510(k) clearances under product code HQE
ApplicantClearances
Storz Instrument Co.16
Medical Instrument Development Laboratories, Inc.14
CooperVision, Inc.7
Site Microsurgical Systems, Inc.7
Optical Micro Systems, Inc.6
Advanced Surgical Products, Inc.5
Visioncare Devices, Inc.5
American Surgical Company, LLC4
Mira, Inc.4
Surgical Technologies, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order