510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HQOClass II

Unit, Cautery, Thermal, Ac-Powered

21 CFR 886.4115 / Ophthalmic
FDA source (opens on fda.gov)

HQO is the FDA product code for Unit, Cautery, Thermal, Ac-Powered, a class II device type, regulated under 21 CFR 886.4115. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HQO
Device name
Unit, Cautery, Thermal, Ac-Powered
Regulation
21 CFR 886.4115
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
12
Ingested recalls
0

Clearances, product code HQO

By decision year
12 clearances under product code HQO with a decision year between 1981 and 2007, 1985 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HQO by decision year
YearClearances
19811
19852
19881
19901
19941
19961
19971
20002
20041
20071

Applicants with the most clearances

Product code HQO
Applicants holding the most 510(k) clearances under product code HQO
ApplicantClearances
Microline Surgical, Inc3
Adler Instrument Company1
Boston Surgical Products, Inc.1
Dutch Ophthalmic USA, Inc.1
Geiger Medical Technologies, Inc.1
Mecron Medical Products, Inc.1
Medical Products Development, Inc.1
Mentor Ophthalmics, Inc.1
Spembly Medical, Ltd.1
Valley Forge Scientific Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code