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
HCIClass II

Applier, Aneurysm Clip

21 CFR 882.4175 / Neurology
FDA source (opens on fda.gov)

HCI is the FDA product code for Applier, Aneurysm Clip, a class II device type, regulated under 21 CFR 882.4175. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
HCI
Device name
Applier, Aneurysm Clip
Regulation
21 CFR 882.4175
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
14
Ingested recalls
5

Clearances, product code HCI

By decision year
14 clearances under product code HCI with a decision year between 1983 and 2022, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HCI by decision year
YearClearances
19831
19882
19901
19951
19961
19981
19991
20001
20011
20171
20181
20211
20221

Applicants with the most clearances

Product code HCI
Applicants holding the most 510(k) clearances under product code HCI
ApplicantClearances
Aesculap Inc5
Downs Surgical, Ltd.2
Advanced Biosearch Assn.1
Cerenovus, Inc.1
Johnson & Johnson Professionals, Inc.1
Medicon, E.G.1
Mizuho America, Inc.1
Nmt Medical, Inc.1
Von Zeppelin GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code