FDA Browser
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
K
22
1713
Polypectomy Snare
2
Cleared 510(K)
K
22
0846
CORE-SNARE
2
Cleared 510(K)
K
22
0089
Disposable Polyp Snare
2
Cleared 510(K)
K
22
0790
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
2
Cleared 510(K)
K
21
3222
Disposable Polypectomy Snare
2
Cleared 510(K)
K
21
2860
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
2
Cleared 510(K)
K
20
2478
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
2
Cleared 510(K)
K
20
0745
Lariat, Hot/Cold Snare
2
Cleared 510(K)
K
19
0512
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
2
Cleared 510(K)
K
19
1048
AcuSnare Polypectomy Snare - Duckbill
2
Cleared 510(K)
K
18
3289
ClearGrasp Snare
2
Cleared 510(K)
K
18
2909
Roth Net Retriever Product Line
2
Cleared 510(K)
K
17
3673
AcuSnare Polypectomy Snare
2
Cleared 510(K)
K
17
2729
Polypectomy Snare
2
Cleared 510(K)
K
17
2758
Rotatable Snares, Non-Rotatable Snares
2
Cleared 510(K)
K
17
2734
Single Use Electrosurgical Snare SD-400
2
Cleared 510(K)
K
16
0637
Rotatable Snares
2
Cleared 510(K)
K
15
2580
rescuenet
2
Cleared 510(K)
K
15
0316
Polypectomy Snare
2
Cleared 510(K)
K
15
1197
Lariat snare
2
Cleared 510(K)
K
14
0923
TRACTION POLYPECTOMY SNARE
2
Cleared 510(K)
K
14
2258
PolyCatch Retrieval Device
2
Cleared 510(K)
K
14
0726
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
2
Cleared 510(K)
K
14
0763
MONOFILAMENT POLYPECTOMY SNARE
2
Cleared 510(K)
K
13
3987
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
2
Cleared 510(K)
K
13
3513
MULTI-STAGE SNARE
2
Cleared 510(K)
K
13
1700
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
2
Cleared 510(K)
K
12
3223
EC SINGLE USE, POLYPECTOMY SNARE
2
Cleared 510(K)
K
12
2462
ROTH NET RETRIEVER
2
Cleared 510(K)
K
10
3611
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
2
Cleared 510(K)
K
09
1355
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
2
Cleared 510(K)
K
08
3049
TORNADO ROTATABEL SNARE AND POLYP CATCHER
2
Cleared 510(K)
K
07
3288
ETHICON ENDO SURGERY ARTICULATING SNARE
2
Cleared 510(K)
K
05
0294
COOK IRELAND SONNET POLYPECTOMY SNARE
2
Cleared 510(K)
K
04
0961
INJECTOR NEEDLE/SNARE
2
Cleared 510(K)
K
02
2268
HORIZONS REUSABLE POLYPECTOMY SNARES
2
Cleared 510(K)
K
02
0891
NAKAO SNARE II AND NAKAO SNARE III
2
Cleared 510(K)
K
01
1667
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
2
Cleared 510(K)
K
00
2927
SNARE,FLEXIBLE
2
Cleared 510(K)
K
99
2477
ROTOSNARE
2
Cleared 510(K)
K
97
1275
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
2
Cleared 510(K)
K
97
0356
IRRIGATION/ASPIRATION POLYPECTOMY
2
Cleared 510(K)
K
96
0230
SNARE
2
Cleared 510(K)
K
95
5650
OLYMPUS SD SERIES SNARES
2
Cleared 510(K)
K
95
1600
MILL-ROSE ROTATABLE POLYPECTOMY SNARE
2
Cleared 510(K)
K
94
3935
GIP/MEDI-GLOBE POLYPECTOMY SNARES
2
Cleared 510(K)
K
95
0496
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
2
Cleared 510(K)
K
94
1750
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
2
Cleared 510(K)
K
94
2110
INJECT-SNARE
2
Cleared 510(K)
K
94
0335
AMERICAN CATHETER POLY-SNARE
2
Cleared 510(K)
K
92
3031
ENDOSNARE
2
Cleared 510(K)
K
93
0022
SPHINCTEROTOME
2
Cleared 510(K)
K
92
4105
SNARE FLEXIBLE
2
Cleared 510(K)
K
92
3671
COX DISPOSABLE POLYPECTOMY SNARES
2
Cleared 510(K)
K
91
2254
COX DIAPOSABLE POLYPECTOMY SNARE
2
Cleared 510(K)
K
91
1482
LAPAROSCOPIC SNARE
2
Cleared 510(K)
K
90
2265
FLEXIBLE SNARE
2
Cleared 510(K)
K
90
1428
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
2
Cleared 510(K)
K
90
1322
DOBBHOFF(R) POLYPECTOMY SNARE
2
Cleared 510(K)
K
89
4869
WILTEK POLYPECTOMY SNARE
2
Cleared 510(K)
K
89
3553
BIPOLAR ELECTROSURGICAL SNARE
2
Cleared 510(K)
K
84
5016
DAVOL POLYPECTOMY SNARE
2
Cleared 510(K)
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 13 December 2024 at 11:05 pm
GU
/
subpart-e—surgical-devices
/
FDI
/
K140923
View Source
TRACTION POLYPECTOMY SNARE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140923
510(k) Type
Traditional
Applicant
OVESCO ENDOSCOPY AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/18/2014
Days to Decision
222 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
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
K
22
1713
Polypectomy Snare
K
22
0846
CORE-SNARE
K
22
0089
Disposable Polyp Snare
K
22
0790
Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare
K
21
3222
Disposable Polypectomy Snare
K
21
2860
SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)
K
20
2478
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
K
20
0745
Lariat, Hot/Cold Snare
K
19
0512
SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare
K
19
1048
AcuSnare Polypectomy Snare - Duckbill
K
18
3289
ClearGrasp Snare
K
18
2909
Roth Net Retriever Product Line
K
17
3673
AcuSnare Polypectomy Snare
K
17
2729
Polypectomy Snare
K
17
2758
Rotatable Snares, Non-Rotatable Snares
K
17
2734
Single Use Electrosurgical Snare SD-400
K
16
0637
Rotatable Snares
K
15
2580
rescuenet
K
15
0316
Polypectomy Snare
K
15
1197
Lariat snare
K
14
0923
TRACTION POLYPECTOMY SNARE
K
14
2258
PolyCatch Retrieval Device
K
14
0726
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV
K
14
0763
MONOFILAMENT POLYPECTOMY SNARE
K
13
3987
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K
13
3513
MULTI-STAGE SNARE
K
13
1700
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
K
12
3223
EC SINGLE USE, POLYPECTOMY SNARE
K
12
2462
ROTH NET RETRIEVER
K
10
3611
UROLOGY MONOPOLAR SNARE FOR TISSUE TRANSECTION
K
09
1355
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998
K
08
3049
TORNADO ROTATABEL SNARE AND POLYP CATCHER
K
07
3288
ETHICON ENDO SURGERY ARTICULATING SNARE
K
05
0294
COOK IRELAND SONNET POLYPECTOMY SNARE
K
04
0961
INJECTOR NEEDLE/SNARE
K
02
2268
HORIZONS REUSABLE POLYPECTOMY SNARES
K
02
0891
NAKAO SNARE II AND NAKAO SNARE III
K
01
1667
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
K
00
2927
SNARE,FLEXIBLE
K
99
2477
ROTOSNARE
K
97
1275
MILL-ROSE DISPOSABLE POLYPECTOMY SNARE
K
97
0356
IRRIGATION/ASPIRATION POLYPECTOMY
K
96
0230
SNARE
K
95
5650
OLYMPUS SD SERIES SNARES
K
95
1600
MILL-ROSE ROTATABLE POLYPECTOMY SNARE
K
94
3935
GIP/MEDI-GLOBE POLYPECTOMY SNARES
K
95
0496
SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
K
94
1750
PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES
K
94
2110
INJECT-SNARE
K
94
0335
AMERICAN CATHETER POLY-SNARE
K
92
3031
ENDOSNARE
K
93
0022
SPHINCTEROTOME
K
92
4105
SNARE FLEXIBLE
K
92
3671
COX DISPOSABLE POLYPECTOMY SNARES
K
91
2254
COX DIAPOSABLE POLYPECTOMY SNARE
K
91
1482
LAPAROSCOPIC SNARE
K
90
2265
FLEXIBLE SNARE
K
90
1428
DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE
K
90
1322
DOBBHOFF(R) POLYPECTOMY SNARE
K
89
4869
WILTEK POLYPECTOMY SNARE
K
89
3553
BIPOLAR ELECTROSURGICAL SNARE
K
84
5016
DAVOL POLYPECTOMY SNARE
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
/
FDI
/
K140923
View Source
TRACTION POLYPECTOMY SNARE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K140923
510(k) Type
Traditional
Applicant
OVESCO ENDOSCOPY AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
11/18/2014
Days to Decision
222 days
Submission Type
Statement