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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
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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
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
K
23
0488
EL27-Compact; Sterile EHL-Probes
2
Cleared 510(K)
K
20
2813
URO-TOUCH 9 French Probe
2
Cleared 510(K)
K
19
1124
Swiss LithoClast Trilogy
2
Cleared 510(K)
K
16
2119
UreTron PF Series Probe
2
Cleared 510(K)
K
16
0198
UreTron MultiProbe Lithotripter System
2
Cleared 510(K)
K
13
2795
CYBERWAND STERILE PROBE SET
2
Cleared 510(K)
K
13
0368
AUTOLITH TOUCH; URO TOUCH
2
Cleared 510(K)
K
12
3038
SWISS LITHOBREAKER
2
Cleared 510(K)
K
12
0303
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
2
Cleared 510(K)
K
11
1058
URETRON MODEL URT
2
Cleared 510(K)
K
10
2169
CYBERWAND LITHOTRIPTER
2
Cleared 510(K)
K
09
2033
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
2
Cleared 510(K)
K
07
2422
CYBERWAND STERILE PADS, MODEL: CW-RBPBX
2
Cleared 510(K)
K
06
2475
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
2
Cleared 510(K)
K
05
2135
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
2
Cleared 510(K)
K
01
1911
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
2
Cleared 510(K)
K
01
1848
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
2
Cleared 510(K)
K
01
2445
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
2
Cleared 510(K)
K
01
1065
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
2
Cleared 510(K)
K
00
2084
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
2
Cleared 510(K)
K
99
2114
KSEA CALCUSPLIT
2
Cleared 510(K)
K
99
2251
SWISS LITHOCLAST MULTIPURPOSE PROBE
2
Cleared 510(K)
K
99
0341
ELECTRO MECHANICAL LITHOTRIPTOR
2
Cleared 510(K)
K
98
0492
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
2
Cleared 510(K)
K
98
1233
KSEA CALCUSPLIT
2
Cleared 510(K)
K
97
4796
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
2
Cleared 510(K)
K
97
3788
MICROVASIVE LIPTHOTRIPSY PROBES
2
Cleared 510(K)
K
97
4164
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
2
Cleared 510(K)
K
96
3285
EMS SWISS LITHOCLAST LITHOTRIPTER
2
Cleared 510(K)
K
95
1531
SWISS LITHOCLAST LITHOTRIPTER
2
Cleared 510(K)
K
94
4571
PULSE GUARD 3FR ELECTRODE
2
Cleared 510(K)
K
93
1755
RIWOLITH 2280 PROBES
2
Cleared 510(K)
K
93
1779
EHL PULSE GENERATOR
2
Cleared 510(K)
K
92
0410
EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
2
Cleared 510(K)
K
92
5396
PULSE GUARD ELECTRODE
2
Cleared 510(K)
K
92
3822
AUTOLITH-IEHL
2
Cleared 510(K)
K
91
4517
SD-200IEHL(TM)
2
Cleared 510(K)
K
91
3487
RIWOLITH 2280
2
Cleared 510(K)
K
91
4515
3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
2
Cleared 510(K)
K
91
4516
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
2
Cleared 510(K)
K
91
4514
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
2
Cleared 510(K)
K
91
3955
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
2
Cleared 510(K)
K
90
5553
LITHOTRIPTOR SYSTEM MODEL 27080
2
Cleared 510(K)
K
90
3337
1.9 FRENCH LITHOTRIPTER ELECTRODE
2
Cleared 510(K)
K
89
4704
2.5 FRENCH LITHOTRIPTOR ELECTRODE
2
Cleared 510(K)
K
89
5178
TECHNOMED PULSOLITH LASER SYSTEM
2
Cleared 510(K)
K
88
5255
MDL-1 LASERTRIPTER(TM)
2
Cleared 510(K)
K
89
0436
TECHNOMED PULSOLITH LASER SYSTEM
2
Cleared 510(K)
K
88
3189
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
2
Cleared 510(K)
K
88
0503
MDL-1 LASERTRIPTER
2
Cleared 510(K)
K
86
4904
3F ELECTRODE
2
Cleared 510(K)
K
86
3642
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
2
Cleared 510(K)
K
85
2874
5F ELECTRODE(LITHOTRIPTOR)
2
Cleared 510(K)
K
83
4228
LITHOTRIPTOR ELECTRODE 4.5F
2
Cleared 510(K)
K
83
2566
COAXIAL ELECTRODE #300A
2
Cleared 510(K)
K
83
0086
4.5 F LITHOTRIPTOR ELECTRODE
2
Cleared 510(K)
K
82
2585
LITHOTRIPTOR ELECTRODE 4.5F
2
Cleared 510(K)
K
82
2644
RIWOLITH 2135
2
Cleared 510(K)
K
80
2322
MODEL SD-1 DISINTEGRATOR
2
Cleared 510(K)
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
/
FFK
/
K990341
View Source
ELECTRO MECHANICAL LITHOTRIPTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990341
510(k) Type
Traditional
Applicant
NORTHGATE TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/14/1999
Days to Decision
161 days
Submission Type
Summary
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
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
K
23
0488
EL27-Compact; Sterile EHL-Probes
K
20
2813
URO-TOUCH 9 French Probe
K
19
1124
Swiss LithoClast Trilogy
K
16
2119
UreTron PF Series Probe
K
16
0198
UreTron MultiProbe Lithotripter System
K
13
2795
CYBERWAND STERILE PROBE SET
K
13
0368
AUTOLITH TOUCH; URO TOUCH
K
12
3038
SWISS LITHOBREAKER
K
12
0303
CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
K
11
1058
URETRON MODEL URT
K
10
2169
CYBERWAND LITHOTRIPTER
K
09
2033
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
K
07
2422
CYBERWAND STERILE PADS, MODEL: CW-RBPBX
K
06
2475
LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
K
05
2135
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
K
01
1911
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
K
01
1848
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
K
01
2445
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
K
01
1065
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
K
00
2084
MICROVASIVE LITHOTRIPTOR FLEXPROBE II
K
99
2114
KSEA CALCUSPLIT
K
99
2251
SWISS LITHOCLAST MULTIPURPOSE PROBE
K
99
0341
ELECTRO MECHANICAL LITHOTRIPTOR
K
98
0492
AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
K
98
1233
KSEA CALCUSPLIT
K
97
4796
LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
K
97
3788
MICROVASIVE LIPTHOTRIPSY PROBES
K
97
4164
SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
K
96
3285
EMS SWISS LITHOCLAST LITHOTRIPTER
K
95
1531
SWISS LITHOCLAST LITHOTRIPTER
K
94
4571
PULSE GUARD 3FR ELECTRODE
K
93
1755
RIWOLITH 2280 PROBES
K
93
1779
EHL PULSE GENERATOR
K
92
0410
EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
K
92
5396
PULSE GUARD ELECTRODE
K
92
3822
AUTOLITH-IEHL
K
91
4517
SD-200IEHL(TM)
K
91
3487
RIWOLITH 2280
K
91
4515
3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K
91
4516
9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K
91
4514
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K
91
3955
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
K
90
5553
LITHOTRIPTOR SYSTEM MODEL 27080
K
90
3337
1.9 FRENCH LITHOTRIPTER ELECTRODE
K
89
4704
2.5 FRENCH LITHOTRIPTOR ELECTRODE
K
89
5178
TECHNOMED PULSOLITH LASER SYSTEM
K
88
5255
MDL-1 LASERTRIPTER(TM)
K
89
0436
TECHNOMED PULSOLITH LASER SYSTEM
K
88
3189
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K
88
0503
MDL-1 LASERTRIPTER
K
86
4904
3F ELECTRODE
K
86
3642
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K
85
2874
5F ELECTRODE(LITHOTRIPTOR)
K
83
4228
LITHOTRIPTOR ELECTRODE 4.5F
K
83
2566
COAXIAL ELECTRODE #300A
K
83
0086
4.5 F LITHOTRIPTOR ELECTRODE
K
82
2585
LITHOTRIPTOR ELECTRODE 4.5F
K
82
2644
RIWOLITH 2135
K
80
2322
MODEL SD-1 DISINTEGRATOR
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
/
FFK
/
K990341
View Source
ELECTRO MECHANICAL LITHOTRIPTOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K990341
510(k) Type
Traditional
Applicant
NORTHGATE TECHNOLOGIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/14/1999
Days to Decision
161 days
Submission Type
Summary