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
HINClass II

Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

21 CFR 884.4150 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HIN is the FDA product code for Coagulator-Cutter, Endoscopic, Bipolar (And Accessories), a class II device type, regulated under 21 CFR 884.4150. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HIN
Device name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Regulation
21 CFR 884.4150
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
Yes
Ingested clearances
16
Ingested recalls
0

Clearances, product code HIN

By decision year
16 clearances under product code HIN with a decision year between 1978 and 2014, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HIN by decision year
YearClearances
19782
19791
19871
19911
19942
19981
19991
20112
20122
20132
20141

Applicants with the most clearances

Product code HIN
Applicants holding the most 510(k) clearances under product code HIN
ApplicantClearances
Gyrus ACMI, Inc.2
Karl Storz Endoscopy-America, Inc.2
Richard Wolf Medical Instruments Corp.2
Ethicon, Inc1
Elmed, Inc.1
Everest Medical Corp.1
Kli1
Kli1
LiNA Medical Inc1
Mectra Labs, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order