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

Insufflator, Laparoscopic

21 CFR 884.1730 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HIF is the FDA product code for Insufflator, Laparoscopic, a class II device type, regulated under 21 CFR 884.1730. As of , FDA records hold 179 510(k) clearances under this code, the most recent dated , and 29 recalls.

Classification record

Product code
HIF
Device name
Insufflator, Laparoscopic
Regulation
21 CFR 884.1730
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
179
Ingested recalls
29

Clearances, product code HIF

By decision year
179 clearances under product code HIF with a decision year between 1978 and 2026, 1994 the highest year at 20.
Show the numbers
510(k) clearances under FDA product code HIF by decision year
YearClearances
19782
19811
19851
19871
19881
19902
199116
199212
19936
199420
199510
19964
19975
19986
19995
20004
20015
20024
20033
20044
20063
20074
20082
20094
20102
20115
20125
20132
20142
20152
20163
20175
20183
20192
20204
20211
20221
20237
20244
20253
20263

Applicants with the most clearances

Product code HIF
Applicants holding the most 510(k) clearances under product code HIF
ApplicantClearances
Northgate Technologies Inc.16
Lexion Medical, LLC.12
Karl Storz Endoscopy-America, Inc.10
Novanta Medical GmbH10
Richard Wolf Medical Instruments Corp.7
ConMed Corporation4
Palliare4
Mectra Labs, Inc.3
MEDLINE INDUSTRIES, LP - Northfield3
Olympus Medical Systems Corp.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 116 companies shown, in name order