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

Pneumoperitoneum Needle

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FHO is the FDA product code for Pneumoperitoneum Needle, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "For establishment of a pneumoperitoneum in abdomen". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FHO
Device name
Pneumoperitoneum Needle
FDA definition
For establishment of a pneumoperitoneum in abdomen.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
15
Ingested recalls
0

Clearances, product code FHO

By decision year
15 clearances under product code FHO with a decision year between 1985 and 2017, 1991 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FHO by decision year
YearClearances
19851
19861
19913
19921
19931
19942
19951
19961
19971
20011
20131
20171

Applicants with the most clearances

Product code FHO
Applicants holding the most 510(k) clearances under product code FHO
ApplicantClearances
Origin Medsystems, Inc.2
CooperSurgical, Inc.1
Clarus Medical Systems, Inc.1
Core Dynamics, Inc.1
Endotherapeutics1
Gibbons Surgical Corp.1
Henke-Sass Wolf, GmbH.1
Linvatec Corporation1
Micro Medical Devices, Inc.1
Ranfac Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order