FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
2
Product Code
HET
Laparoscope, Gynecologic (And Accessories)
2
Product Code
HEW
Culdoscope (And Accessories)
2
Product Code
HEX
Colposcope (And Colpomicroscope)
2
Product Code
K
23
3043
Smart Scope® CX
2
Cleared 510(K)
K
19
0187
Gynescope System
2
Cleared 510(K)
K
18
2764
Biop Digital Colposcope
2
Cleared 510(K)
K
18
1034
Pocket Colposcope System
2
Cleared 510(K)
K
17
0446
LT-300 SD Digital Video Colposcope
2
Cleared 510(K)
K
16
1871
EVA (Enhanced Visual Assessment) System
2
Cleared 510(K)
K
16
0341
Colposcope System
2
Cleared 510(K)
K
16
0380
LT-300 HD
2
Cleared 510(K)
K
15
1878
Video Colposcope
2
Cleared 510(K)
K
14
3119
LT-300 Video Colposcope
2
Cleared 510(K)
K
14
0754
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
2
Cleared 510(K)
K
13
2423
THE GYNOCULAR
2
Cleared 510(K)
K
12
2311
GC-3000E DIGITAL COLPOSCOPE
2
Cleared 510(K)
K
12
2973
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
2
Cleared 510(K)
K
11
0147
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
2
Cleared 510(K)
K
09
2433
DYSIS
2
Cleared 510(K)
K
09
0324
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
2
Cleared 510(K)
K
10
1141
SEILER COLPOSCOPE, MODELS 935, 955 AND 985
2
Cleared 510(K)
K
10
0595
ECLERIS MICROSTAR COLPOSCOPE
2
Cleared 510(K)
K
07
2691
CERVICAL MD, MODEL C10
2
Cleared 510(K)
K
07
3053
COLPO-MASTER
2
Cleared 510(K)
K
07
0845
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
2
Cleared 510(K)
K
06
1306
CO-1000 COLPOSCOPE, MULTIPLE
2
Cleared 510(K)
K
03
3870
IMAGE MANAGEMENT SYSTEM
2
Cleared 510(K)
K
03
1436
MEDISCOPE
2
Cleared 510(K)
K
03
1639
INTERMED ZOOM COLPOSCOPE
2
Cleared 510(K)
K
02
1153
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
2
Cleared 510(K)
K
02
1854
DFV CPG COLPOSCOPE
2
Cleared 510(K)
K
00
1314
MEDSCOPE
2
Cleared 510(K)
K
00
0707
LEICA COLPOSCOPE
2
Cleared 510(K)
K
99
2544
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
2
Cleared 510(K)
K
98
1958
LEISEGANG VIDEO COLPOSCOPE
2
Cleared 510(K)
K
97
2630
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
2
Cleared 510(K)
K
96
3593
IMT LOUPE-COLPOSCOPE
2
Cleared 510(K)
K
95
5635
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
2
Cleared 510(K)
K
94
0094
COLPOSCOPES AND ACCESSORIES
2
Cleared 510(K)
K
93
2896
HM-0690 COLPOSCOPE
2
Cleared 510(K)
K
93
2782
HM-0660
2
Cleared 510(K)
K
91
3365
ACCUSCOPE(TM) & ACCUSCOPE II(TM)
2
Cleared 510(K)
K
90
2313
LM-1Z ZOOM SCOPE
2
Cleared 510(K)
K
90
3213
ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002
2
Cleared 510(K)
K
89
0387
MALLEABLE PLACENTA CURETTE
2
Cleared 510(K)
K
88
4934
JEDMED KP6 COLPOSCOPE
2
Cleared 510(K)
K
88
0195
GYNESCOPE
2
Cleared 510(K)
K
87
1681
PHOTOSTAR V-8
2
Cleared 510(K)
K
87
1683
COLPOSTAR V-6
2
Cleared 510(K)
K
87
1682
WALLACH CONVERTIBLE COLPOSCOPE
2
Cleared 510(K)
K
85
3389
WALLACH ZOOM COLPOSCOPE
2
Cleared 510(K)
K
85
2980
OCS-2 COLPOSCOPE
2
Cleared 510(K)
K
82
1616
CERVISCOPE OPTICAL SYSTEM
2
Cleared 510(K)
K
80
1730
KRYMED SYSTEM 4001 TILT SCOPE
2
Cleared 510(K)
K
79
1279
KOLPOSKOP KP20005
2
Cleared 510(K)
K
77
0896
COLPOSCOPE MODEL II
2
Cleared 510(K)
K
77
0697
COLPOSCOPE SYSTEM
2
Cleared 510(K)
K
76
1205
DYNATECH JD7/JD7P COLPOSCOPE
2
Cleared 510(K)
K
76
0763
COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I
2
Cleared 510(K)
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
2
Product Code
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
F
Product Code
HFC
Aspirator, Endocervical
2
Product Code
HFD
Washer, Endometrial
2
Product Code
HFE
Brush, Endometrial
2
Product Code
HFF
Aspirator, Endometrial
2
Product Code
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
2
Product Code
HGW
Sampler, Blood, Fetal
2
Product Code
HHK
Curette, Suction, Endometrial (And Accessories)
2
Product Code
HIF
Insufflator, Laparoscopic
2
Product Code
HIG
Insufflator, Hysteroscopic
2
Product Code
HIH
Hysteroscope (And Accessories)
2
Product Code
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
1
Product Code
LHZ
Viscometer, Mucus, Cervical
1
Product Code
MKO
Falloposcope
2
Product Code
MOK
Vaginoscope And Accessories
2
Product Code
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
1
Product Code
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
2
Product Code
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
1
Product Code
NVT
Tubing And Tubing/Filter Fits
1
Product Code
NWV
Laparoscopic Accessories, Gynecologic
1
Product Code
NWW
Hysteroscope Accessories
1
Product Code
PCF
Sampler, Endocervical
2
Product Code
OHD
Gynecological Laparoscopic Kit
2
Product Code
OHE
Forensic Evidence Sexual Assault Kit
2
Product Code
OHF
Culdocentesis Kit
2
Product Code
OHM
Cesarean Section Tray
2
Product Code
OKX
Trocar Kit
2
Product Code
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
2
Product Code
OKZ
Endometrial Sampling Kit
2
Product Code
OSV
Insufflator, Endoscopic Vessel Harvesting
2
Product Code
PTZ
Colposcope (And Colpomicroscope), Exempt
2
Product Code
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
2
Product Code
QHZ
Seal, Cervical, Mechanical, Unpowered
1
Product Code
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
OB
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
HEX
/
K021854
View Source
DFV CPG COLPOSCOPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K021854
510(k) Type
Traditional
Applicant
D.F. VASCONCELLOS S.A.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2002
Days to Decision
141 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
HES
Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)
HET
Laparoscope, Gynecologic (And Accessories)
HEW
Culdoscope (And Accessories)
HEX
Colposcope (And Colpomicroscope)
K
23
3043
Smart Scope® CX
K
19
0187
Gynescope System
K
18
2764
Biop Digital Colposcope
K
18
1034
Pocket Colposcope System
K
17
0446
LT-300 SD Digital Video Colposcope
K
16
1871
EVA (Enhanced Visual Assessment) System
K
16
0341
Colposcope System
K
16
0380
LT-300 HD
K
15
1878
Video Colposcope
K
14
3119
LT-300 Video Colposcope
K
14
0754
COOPER SURGICAL LEISEGANG COLPOSCOPE SYSTEM
K
13
2423
THE GYNOCULAR
K
12
2311
GC-3000E DIGITAL COLPOSCOPE
K
12
2973
AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE
K
11
0147
ULTRASIGHTHD C31 WITH IMAGESENSE AND REMOTE VIEWER TELEMEDICINE
K
09
2433
DYSIS
K
09
0324
ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY
K
10
1141
SEILER COLPOSCOPE, MODELS 935, 955 AND 985
K
10
0595
ECLERIS MICROSTAR COLPOSCOPE
K
07
2691
CERVICAL MD, MODEL C10
K
07
3053
COLPO-MASTER
K
07
0845
SOUNMED COLOPOSCOPE COLPO-99/99PLUS
K
06
1306
CO-1000 COLPOSCOPE, MULTIPLE
K
03
3870
IMAGE MANAGEMENT SYSTEM
K
03
1436
MEDISCOPE
K
03
1639
INTERMED ZOOM COLPOSCOPE
K
02
1153
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
K
02
1854
DFV CPG COLPOSCOPE
K
00
1314
MEDSCOPE
K
00
0707
LEICA COLPOSCOPE
K
99
2544
TRANSVAGINAL HYDRO LAPAROSCOPY (THL) SYSTEM
K
98
1958
LEISEGANG VIDEO COLPOSCOPE
K
97
2630
COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM
K
96
3593
IMT LOUPE-COLPOSCOPE
K
95
5635
VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
K
94
0094
COLPOSCOPES AND ACCESSORIES
K
93
2896
HM-0690 COLPOSCOPE
K
93
2782
HM-0660
K
91
3365
ACCUSCOPE(TM) & ACCUSCOPE II(TM)
K
90
2313
LM-1Z ZOOM SCOPE
K
90
3213
ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002
K
89
0387
MALLEABLE PLACENTA CURETTE
K
88
4934
JEDMED KP6 COLPOSCOPE
K
88
0195
GYNESCOPE
K
87
1681
PHOTOSTAR V-8
K
87
1683
COLPOSTAR V-6
K
87
1682
WALLACH CONVERTIBLE COLPOSCOPE
K
85
3389
WALLACH ZOOM COLPOSCOPE
K
85
2980
OCS-2 COLPOSCOPE
K
82
1616
CERVISCOPE OPTICAL SYSTEM
K
80
1730
KRYMED SYSTEM 4001 TILT SCOPE
K
79
1279
KOLPOSKOP KP20005
K
77
0896
COLPOSCOPE MODEL II
K
77
0697
COLPOSCOPE SYSTEM
K
76
1205
DYNATECH JD7/JD7P COLPOSCOPE
K
76
0763
COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I
HEZ
Endoscope, Transcervical (Amnioscope)(And Accessories)
HFA
Amnioscope, Transabdominal (Fetoscope) (And Accessories)
HFC
Aspirator, Endocervical
HFD
Washer, Endometrial
HFE
Brush, Endometrial
HFF
Aspirator, Endometrial
HGK
Endoscope, Fetal Blood Sampling (And Accessories)
HGW
Sampler, Blood, Fetal
HHK
Curette, Suction, Endometrial (And Accessories)
HIF
Insufflator, Laparoscopic
HIG
Insufflator, Hysteroscopic
HIH
Hysteroscope (And Accessories)
HIO
Sampler, Amniotic Fluid (Amniocentesis Tray)
LHZ
Viscometer, Mucus, Cervical
MKO
Falloposcope
MOK
Vaginoscope And Accessories
NKC
Tubing/Tubing With Filter, Insufflation, Laparoscopic
NMH
Laparoscope And Accessories, Gynecologic, Reprocessed
NMI
Laparoscopic Insufflator And Accessories, Reprocessed
NVT
Tubing And Tubing/Filter Fits
NWV
Laparoscopic Accessories, Gynecologic
NWW
Hysteroscope Accessories
PCF
Sampler, Endocervical
OHD
Gynecological Laparoscopic Kit
OHE
Forensic Evidence Sexual Assault Kit
OHF
Culdocentesis Kit
OHM
Cesarean Section Tray
OKX
Trocar Kit
PGT
Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
OKZ
Endometrial Sampling Kit
OSV
Insufflator, Endoscopic Vessel Harvesting
PTZ
Colposcope (And Colpomicroscope), Exempt
PVS
Fetal Blood Sampling Kit (Excludes Hiv Testing)
QHZ
Seal, Cervical, Mechanical, Unpowered
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-b—obstetrical-and-gynecological-diagnostic-devices
/
HEX
/
K021854
View Source
DFV CPG COLPOSCOPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K021854
510(k) Type
Traditional
Applicant
D.F. VASCONCELLOS S.A.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/25/2002
Days to Decision
141 days
Submission Type
Summary