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

Speculum, Vaginal, Nonmetal, Fiberoptic

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HIC is the FDA product code for Speculum, Vaginal, Nonmetal, Fiberoptic, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HIC
Device name
Speculum, Vaginal, Nonmetal, Fiberoptic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code HIC

By decision year
5 clearances under product code HIC with a decision year between 1985 and 1996, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HIC by decision year
YearClearances
19851
19902
19941
19961

Applicants with the most clearances

Product code HIC
Applicants holding the most 510(k) clearances under product code HIC
ApplicantClearances
Galenica Enterprises, Inc.1
Sims Surgical, Inc.1
Centurion Medical Products, LP1
Trylon Associates, Ltd.1
Trylon Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code