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

Clip, Aneurysm

21 CFR 882.5200 / Neurology
FDA source (opens on fda.gov)

HCH is the FDA product code for Clip, Aneurysm, a class II device type, regulated under 21 CFR 882.5200. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
HCH
Device name
Clip, Aneurysm
Regulation
21 CFR 882.5200
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
4

Clearances, product code HCH

By decision year
36 clearances under product code HCH with a decision year between 1976 and 2022, 2001 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HCH by decision year
YearClearances
19761
19771
19792
19831
19842
19851
19901
19922
19951
19962
19972
19982
19991
20002
20014
20033
20041
20071
20081
20092
20141
20191
20221

Applicants with the most clearances

Product code HCH
Applicants holding the most 510(k) clearances under product code HCH
ApplicantClearances
Aesculap Inc10
Cerenovus, Inc.4
Mizuho America, Inc.3
Advanced Biosearch Assn.2
Edward Weck, Inc.2
Peter Lazic GmbH2
V. Mueller Neuro/Spine2
Aesculap Instruments Corp.1
Cardinalhealth1
Elekta Instruments, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code