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
HFIClass II

Coagulator, Culdoscopic (And Accessories)

21 CFR 884.4160 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HFI is the FDA product code for Coagulator, Culdoscopic (And Accessories), a class II device type, regulated under 21 CFR 884.4160. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HFI
Device name
Coagulator, Culdoscopic (And Accessories)
Regulation
21 CFR 884.4160
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
8
Ingested recalls
0

Clearances, product code HFI

By decision year
8 clearances under product code HFI with a decision year between 1984 and 2015, 1994 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code HFI by decision year
YearClearances
19841
19946
20151

Applicants with the most clearances

Product code HFI
Applicants holding the most 510(k) clearances under product code HFI
ApplicantClearances
Zinnanti Surgical Instruments, Inc.2
Canon Medical Components U.S.A., Inc.1
Cook Incorporated1
Endo Technic Corp.1
Endoplus1
Numed Technologies, Inc.1
Snowden-Pencer1

Companies listing this code with FDA

Companies whose registered establishments list this code