HFI · Class II · 21 CFR 884.4160

FDA Product Code HFI: Coagulator, Culdoscopic (and Accessories)

Leading manufacturers include Zinnanti Surgical Instruments, Inc., Endoplus and Canon USA, Inc..

8
Total
8
Cleared
361d
Avg days
1984
Since

FDA 510(k) Cleared Coagulator, Culdoscopic (and Accessories) Devices (Product Code HFI)

8 devices
1–8 of 8
Cleared Dec 23, 2015
ENDOPLUS hand-held laparoscopic instruments
K151567
Endoplus
Obstetrics & Gynecology · 196d
Cleared Jun 07, 1994
SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925957
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 560d
Cleared Jun 07, 1994
FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
K925960
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 560d
Cleared Mar 11, 1994
COOK LAPAROSCOPIC MINI RETRACTOR SET
K936026
Cook Urological, Inc.
Obstetrics & Gynecology · 84d
Cleared Feb 28, 1994
DIAMOND-SHARP(R) TROCARS
K924148
Snowden-Pencer
Obstetrics & Gynecology · 559d
Cleared Feb 28, 1994
LAPAROSCOPIC INSTRUMENTS
K925114
Endo Technic Corp.
Obstetrics & Gynecology · 507d
Cleared Feb 01, 1994
REUSABLE HANDLE FOR LAPAROSCOPIC INST. W/ROTATING
K930571
Numed Technologies, Inc.
Obstetrics & Gynecology · 362d
Cleared Dec 19, 1984
CANON 60 DEGREE FUNDUS CAMERA CF-60S
K844053
Canon USA, Inc.
Obstetrics & Gynecology · 62d

About Product Code HFI - Regulatory Context