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

Clip, Scalp

21 CFR 882.4150 / Neurology
FDA source (opens on fda.gov)

HBO is the FDA product code for Clip, Scalp, a class II device type, regulated under 21 CFR 882.4150. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HBO
Device name
Clip, Scalp
Regulation
21 CFR 882.4150
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
11
Ingested recalls
3

Clearances, product code HBO

By decision year
11 clearances under product code HBO with a decision year between 1988 and 2026, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HBO by decision year
YearClearances
19882
19892
19901
19911
19941
20011
20041
20051
20261

Applicants with the most clearances

Product code HBO
Applicants holding the most 510(k) clearances under product code HBO
ApplicantClearances
Cerenovus, Inc.2
Acra Cut, Inc.1
Aesculap Instruments Corp.1
Aesculap Inc1
Beijing Honghugaoxiang Science and Technology Development Co1
Medtronic Neurosurgery1
New England Surgical Instrument Corp.1
Omni Medical Designs1
Rudolf Storz GmbH1
Zimmer GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order