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
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
FAD
Stent, Ureteral
2
Product Code
EXX
Probe, Rectal, Non-Powered
1
Product Code
EYD
Stirrups
1
Product Code
EYH
Table, Cysto, Non-Electrical
1
Product Code
EYS
Ribdam
1
Product Code
EZO
Urethrotome
2
Product Code
EZP
Rod, Colostomy
2
Product Code
FAR
Unit, Electrosurgical
2
Product Code
FAS
Electrode, Electrosurgical, Active, Urological
2
Product Code
K
24
0504
PLASMA EDGE System
2
Cleared 510(K)
K
21
3135
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
2
Cleared 510(K)
K
21
0651
Resection Electrodes with HF cable
2
Cleared 510(K)
K
21
0394
Electrosurgical accessory
2
Cleared 510(K)
K
17
1965
Resection Electrodes with HF cable
2
Cleared 510(K)
K
16
3090
Plasma Edge System
2
Cleared 510(K)
K
15
1976
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
2
Cleared 510(K)
K
15
2092
Resection Electrodes
2
Cleared 510(K)
K
12
0567
GYRUS AMCI PK BUTTON ELECTRODE
2
Cleared 510(K)
K
12
0418
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
2
Cleared 510(K)
K
10
2781
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
2
Cleared 510(K)
K
10
0275
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
2
Cleared 510(K)
K
09
3181
GYRUS ACMI PK BUTTON ELECTRODE
2
Cleared 510(K)
K
09
1511
MODERN MEDICAL RESECTOSCOPE ELECTRODES
2
Cleared 510(K)
K
06
1541
KSEA BIPOLAR ELECTROTOME
2
Cleared 510(K)
K
05
3322
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
2
Cleared 510(K)
K
05
0910
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
2
Cleared 510(K)
K
05
0454
OMNITECH FULGURATING ELECTRODE
2
Cleared 510(K)
K
05
0488
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
2
Cleared 510(K)
K
03
1029
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
2
Cleared 510(K)
K
03
1001
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
2
Cleared 510(K)
K
02
2543
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
2
Cleared 510(K)
K
99
1314
COAGULOOP
2
Cleared 510(K)
K
98
1256
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
2
Cleared 510(K)
K
97
3820
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
2
Cleared 510(K)
K
97
4637
ELECTRODES/PROBES/DEVICES
2
Cleared 510(K)
K
97
4516
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
2
Cleared 510(K)
K
97
4515
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
2
Cleared 510(K)
K
97
1512
AMS COAGULOOP RESECTION ELECTRODE
2
Cleared 510(K)
K
97
0526
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
2
Cleared 510(K)
K
97
0717
VAPOR-TECH SLED ELECTRODE
2
Cleared 510(K)
K
96
4365
RESECTOSCOPE CUTTING LOOP ELECTRODE
2
Cleared 510(K)
K
96
5093
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
2
Cleared 510(K)
K
96
5118
ENDOCARE MONOPOLAR ELECTRODE
2
Cleared 510(K)
K
96
2653
MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
2
Cleared 510(K)
K
96
2538
BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)
2
Cleared 510(K)
K
96
1841
BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)
2
Cleared 510(K)
K
95
3983
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
2
Cleared 510(K)
K
96
1702
KSEA VAPORIZATION ELECTRODES
2
Cleared 510(K)
K
96
1069
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
2
Cleared 510(K)
K
95
4710
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
2
Cleared 510(K)
K
95
5531
ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
2
Cleared 510(K)
K
95
3453
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
2
Cleared 510(K)
K
95
1863
ROLLER ELECTRODE
2
Cleared 510(K)
K
95
1897
POWER RESECTOSCOPE CUTTING LOOP
2
Cleared 510(K)
K
94
5191
ENDOSCOPIC ACCESSORY
2
Cleared 510(K)
K
94
3879
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
2
Cleared 510(K)
K
94
4795
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
2
Cleared 510(K)
K
93
1763
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
2
Cleared 510(K)
K
93
3174
GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
2
Cleared 510(K)
K
93
3175
GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
2
Cleared 510(K)
K
93
3173
GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
2
Cleared 510(K)
K
91
5219
URETHRAL ELECTRODE SHEATH
2
Cleared 510(K)
K
90
5731
FLEXIBLE ENDOSCOPIC ELECTRODE
2
Cleared 510(K)
K
90
3162
FLEXIBLE ENDOSCOPIC ELECTRODES
2
Cleared 510(K)
K
90
3156
CONTROL-TIP CYSTOSCOPIC ELECTRODES
2
Cleared 510(K)
FBJ
Cord, Electric For Transurethral Surgical Instrument
2
Product Code
FBS
Sound, Metal, Interconnected
1
Product Code
FCH
Tray, Biopsy, Without Biopsy Instruments
1
Product Code
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
2
Product Code
FDB
Plate, Patient
2
Product Code
FDG
Retractor, Fiberoptic
1
Product Code
FDI
Snare, Flexible
2
Product Code
FDJ
Snare, Rigid Self-Opening
2
Product Code
FDL
Wristlet, Patient Return
2
Product Code
FEH
Electrode, Flexible Suction Coagulator
2
Product Code
FEO
Lithotriptor, Ultrasonic
2
Product Code
FFD
Evacuator, Bladder, Manually Operated
1
Product Code
FFE
System, Water Jet Catheter, Renal
2
Product Code
FFI
System, Alarm, Electrosurgical
2
Product Code
FFK
Lithotriptor, Electro-Hydraulic
2
Product Code
FFL
Dislodger, Stone, Basket, Ureteral, Metal
2
Product Code
FFN
Clamp, Non-Electrical
1
Product Code
FFO
Retractor, Self-Retaining
1
Product Code
FFQ
Speculum, Rectal
1
Product Code
FFR
Device, Locking, For Intestinal Clamp
1
Product Code
FGK
Tripsor, Stone, Bladder
2
Product Code
FGM
Probe And Director, Gastro-Urology
1
Product Code
FGN
Retractor, Non-Self-Retaining
1
Product Code
FGO
Dislodger, Stone, Flexible
2
Product Code
FGW
Clamp, Electrical
2
Product Code
FGX
Snare, Non-Electrical
1
Product Code
FHB
Hook, Gastro-Urology
1
Product Code
FHC
Adaptor To The Cord, For Transurethral Surgical Instrument
2
Product Code
FHF
System, Evacuator, Fluid
2
Product Code
FHH
Crusher, Spur, Colostomy
1
Product Code
FHI
Ring, Laparotomy
1
Product Code
FHK
Spreader, Bladder Neck
1
Product Code
FHL
Scoop
1
Product Code
FHN
Ligator, Hemorrhoidal
2
Product Code
FHQ
Holder, Needle, Gastroenterologic
1
Product Code
FHY
Jelly, Contact, For Transurethral Surgical Instrument
2
Product Code
FHZ
Desiccator, Transurethral
2
Product Code
FKK
Clamp, Line
1
Product Code
KGE
Forceps, Biopsy, Electric
2
Product Code
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
2
Product Code
KOA
Surgical Instruments, G-U, Manual (And Accessories)
1
Product Code
KQS
Table, Cystometric, Non-Electric And Accessories
1
Product Code
KQT
Evacuator, Gastro-Urology
2
Product Code
LQC
Lithotriptor, Biliary Mechanical
2
Product Code
MMZ
Table, Cystometric, Electric
2
Product Code
MND
Ligator, Esophageal
2
Product Code
NLR
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
2
Product Code
NLT
Snare, Flexible, Reprocessed
2
Product Code
NLU
Forceps, Biopsy, Electric, Reprocessed
2
Product Code
NLV
Electrode, Flexible Suction Coagulator, Reprocessed
2
Product Code
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
2
Product Code
NQT
Dislodger, Stone, Flexible, Ureteral, Reprocessed
2
Product Code
NQU
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
2
Product Code
NWI
Electrosurgical Electrode Kit
2
Product Code
OLH
Orchidometer
1
Product Code
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
2
Product Code
OOW
Applicator For Rectal Suppository
1
Product Code
PKL
Hemostatic Metal Clip For The Gi Tract
2
Product Code
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
2
Product Code
PRU
Gastric Lavage Kit (Adult Or Pediatric Use)
2
Product Code
QGB
Ureteral Stent Accessories
1
Product Code
PVY
Vasovasostomy Set
1
Product Code
QNE
Endoscopic Pancreatic Debridement Device
2
Product Code
QAG
Endoscopic Electrosurgical Clip Cutting System
2
Product Code
LNK
Laser For Gastro-Urology Use
2
Product Code
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
2
Product Code
NEJ
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
2
Product Code
PZP
Fluid Jet Removal System
2
Product Code
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
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 6 December 2024 at 11:05 pm
GU
/
subpart-e—surgical-devices
/
FAS
/
K974637
View Source
ELECTRODES/PROBES/DEVICES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974637
510(k) Type
Traditional
Applicant
XIMED/PROSURE/INJECTX
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/1998
Days to Decision
26 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart E—Surgical Devices
FAD
Stent, Ureteral
EXX
Probe, Rectal, Non-Powered
EYD
Stirrups
EYH
Table, Cysto, Non-Electrical
EYS
Ribdam
EZO
Urethrotome
EZP
Rod, Colostomy
FAR
Unit, Electrosurgical
FAS
Electrode, Electrosurgical, Active, Urological
K
24
0504
PLASMA EDGE System
K
21
3135
Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge
K
21
0651
Resection Electrodes with HF cable
K
21
0394
Electrosurgical accessory
K
17
1965
Resection Electrodes with HF cable
K
16
3090
Plasma Edge System
K
15
1976
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
K
15
2092
Resection Electrodes
K
12
0567
GYRUS AMCI PK BUTTON ELECTRODE
K
12
0418
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES
K
10
2781
RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS
K
10
0275
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS
K
09
3181
GYRUS ACMI PK BUTTON ELECTRODE
K
09
1511
MODERN MEDICAL RESECTOSCOPE ELECTRODES
K
06
1541
KSEA BIPOLAR ELECTROTOME
K
05
3322
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
K
05
0910
ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
K
05
0454
OMNITECH FULGURATING ELECTRODE
K
05
0488
TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES
K
03
1029
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K
03
1001
ACMI VISTA CTR BIPOLAR LOOP ELECTRODE
K
02
2543
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K
99
1314
COAGULOOP
K
98
1256
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
K
97
3820
USA ELITE SYSTEM VAPORTRODE VAPORIZATION ELECTRODE AND VAPORTOME RESECTION ELECTRODE
K
97
4637
ELECTRODES/PROBES/DEVICES
K
97
4516
ENDOLAP RESECTOSCOPE CUTTING LOOP ELECTRODE
K
97
4515
ENDOLAP RESECTOSCOPE ROLLER ELECTRODE
K
97
1512
AMS COAGULOOP RESECTION ELECTRODE
K
97
0526
ARTHROCARE MONOPOLAR ELECTROSURGERY LOOP
K
97
0717
VAPOR-TECH SLED ELECTRODE
K
96
4365
RESECTOSCOPE CUTTING LOOP ELECTRODE
K
96
5093
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K
96
5118
ENDOCARE MONOPOLAR ELECTRODE
K
96
2653
MICROGYN RESECTION LOOP, COAGULATING ELECTRODE, CISS SHEATH ELECTRODE, LOOP ELECTRODE KIT AND COAGULATING ELECTRODE KIT
K
96
2538
BARD COAGULATING RESECTOR MODEL (3552XX; XX=01,02,03,04,05 OR 06)
K
96
1841
BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06)
K
95
3983
EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE
K
96
1702
KSEA VAPORIZATION ELECTRODES
K
96
1069
ARTHROCARE UROLOGIC MULTI-ELECTRODE ELECTROSURGERY SYSTEM
K
95
4710
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
K
95
5531
ARTHROCARE BIPOLAR LOOP ELECTRODE SYSTEM
K
95
3453
SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
K
95
1863
ROLLER ELECTRODE
K
95
1897
POWER RESECTOSCOPE CUTTING LOOP
K
94
5191
ENDOSCOPIC ACCESSORY
K
94
3879
RESECTOSCOPE ELECTRO CAUTERY CUTTING LOOP
K
94
4795
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
K
93
1763
HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS
K
93
3174
GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE
K
93
3175
GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE
K
93
3173
GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE
K
91
5219
URETHRAL ELECTRODE SHEATH
K
90
5731
FLEXIBLE ENDOSCOPIC ELECTRODE
K
90
3162
FLEXIBLE ENDOSCOPIC ELECTRODES
K
90
3156
CONTROL-TIP CYSTOSCOPIC ELECTRODES
FBJ
Cord, Electric For Transurethral Surgical Instrument
FBS
Sound, Metal, Interconnected
FCH
Tray, Biopsy, Without Biopsy Instruments
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
FDB
Plate, Patient
FDG
Retractor, Fiberoptic
FDI
Snare, Flexible
FDJ
Snare, Rigid Self-Opening
FDL
Wristlet, Patient Return
FEH
Electrode, Flexible Suction Coagulator
FEO
Lithotriptor, Ultrasonic
FFD
Evacuator, Bladder, Manually Operated
FFE
System, Water Jet Catheter, Renal
FFI
System, Alarm, Electrosurgical
FFK
Lithotriptor, Electro-Hydraulic
FFL
Dislodger, Stone, Basket, Ureteral, Metal
FFN
Clamp, Non-Electrical
FFO
Retractor, Self-Retaining
FFQ
Speculum, Rectal
FFR
Device, Locking, For Intestinal Clamp
FGK
Tripsor, Stone, Bladder
FGM
Probe And Director, Gastro-Urology
FGN
Retractor, Non-Self-Retaining
FGO
Dislodger, Stone, Flexible
FGW
Clamp, Electrical
FGX
Snare, Non-Electrical
FHB
Hook, Gastro-Urology
FHC
Adaptor To The Cord, For Transurethral Surgical Instrument
FHF
System, Evacuator, Fluid
FHH
Crusher, Spur, Colostomy
FHI
Ring, Laparotomy
FHK
Spreader, Bladder Neck
FHL
Scoop
FHN
Ligator, Hemorrhoidal
FHQ
Holder, Needle, Gastroenterologic
FHY
Jelly, Contact, For Transurethral Surgical Instrument
FHZ
Desiccator, Transurethral
FKK
Clamp, Line
KGE
Forceps, Biopsy, Electric
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
KOA
Surgical Instruments, G-U, Manual (And Accessories)
KQS
Table, Cystometric, Non-Electric And Accessories
KQT
Evacuator, Gastro-Urology
LQC
Lithotriptor, Biliary Mechanical
MMZ
Table, Cystometric, Electric
MND
Ligator, Esophageal
NLR
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
NLT
Snare, Flexible, Reprocessed
NLU
Forceps, Biopsy, Electric, Reprocessed
NLV
Electrode, Flexible Suction Coagulator, Reprocessed
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
NQT
Dislodger, Stone, Flexible, Ureteral, Reprocessed
NQU
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
NWI
Electrosurgical Electrode Kit
OLH
Orchidometer
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
OOW
Applicator For Rectal Suppository
PKL
Hemostatic Metal Clip For The Gi Tract
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
PRU
Gastric Lavage Kit (Adult Or Pediatric Use)
QGB
Ureteral Stent Accessories
PVY
Vasovasostomy Set
QNE
Endoscopic Pancreatic Debridement Device
QAG
Endoscopic Electrosurgical Clip Cutting System
LNK
Laser For Gastro-Urology Use
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
NEJ
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
PZP
Fluid Jet Removal System
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
GU
/
subpart-e—surgical-devices
/
FAS
/
K974637
View Source
ELECTRODES/PROBES/DEVICES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974637
510(k) Type
Traditional
Applicant
XIMED/PROSURE/INJECTX
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/7/1998
Days to Decision
26 days
Submission Type
Statement