Laparoscope, General & Plastic Surgery

Device Code: 5457

Product Code(s): GCJ

Definition: Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 FR 26807, Available At Https:/

Device Classification Information

Device Type ID5457
Device NameLaparoscope, General & Plastic Surgery
Regulation DescriptionEndoscope And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(k)
CFR Regulation Number876.1500 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeGCJ
GMP ExemptNo
Summary MRIneligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5457
DeviceLaparoscope, General & Plastic Surgery
Product CodeGCJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndoscope And Accessories.
CFR Regulation Number876.1500 [🔎]
Premarket Reviews
ManufacturerDecision
ABMEDICA SAS
 
SUBSTANTIALLY EQUIVALENT
 1
AESCULAP
 
SUBSTANTIALLY EQUIVALENT
 2
AESCULAP, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
APPLIED MEDICAL RESOURCES
 
SUBSTANTIALLY EQUIVALENT
 2
APPLIED MEDICAL RESOURCES CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
ARTHREX, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BANYAN MEDICAL, LLC.
 
SUBSTANTIALLY EQUIVALENT
 1
BEACON SURGICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
BEIJING HANGTIAN KADI TECHNOLOGY R&D INSTITUTE
 
SUBSTANTIALLY EQUIVALENT
 1
BOEHRINGER LABORATORIES, INC
 
SUBSTANTIALLY EQUIVALENT
 1
BUFFALO FILTER, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
CAREFUSION 2200 INC.
 
SUBSTANTIALLY EQUIVALENT
 1
CONMED
 
SUBSTANTIALLY EQUIVALENT
 5
CONMED CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 5
COOK, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
COVIDIEN
 
SUBSTANTIALLY EQUIVALENT
 7
COVIDIEN LLC
 
SUBSTANTIALLY EQUIVALENT
 3
DEROYAL
 
SUBSTANTIALLY EQUIVALENT
 1
DEROYAL INDUSTRIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
DESIGN STANDARDS CORP.
 
SUBSTANTIALLY EQUIVALENT
 1
ELMED
 
SUBSTANTIALLY EQUIVALENT
 1
ENDOCLOT PLUS CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
GENICON
 
SUBSTANTIALLY EQUIVALENT
 1
GENICON INC
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBUS
 
SUBSTANTIALLY EQUIVALENT
 1
GLOBUS MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
INTUITIVE SURGICAL, INC.
 
SE - WITH LIMITATIONS
 1
 
SUBSTANTIALLY EQUIVALENT
 4
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO.,LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
KARL STORZ GMBH & CO. KG
 
SUBSTANTIALLY EQUIVALENT
 3
KARL STORZ SE & CO KG
 
SUBSTANTIALLY EQUIVALENT
 3
LAGIS ENTERPRISES CO, LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
LG ELECTRONICS
 
SUBSTANTIALLY EQUIVALENT
 1
LIVAC PTY LTD
 
SUBSTANTIALLY EQUIVALENT
 1
LUMENIS LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
LUMENIS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDEON BIODESIGN, INC
 
SUBSTANTIALLY EQUIVALENT
 3
MINIMMALLY INVASIVE DEVICES
 
SUBSTANTIALLY EQUIVALENT
 1
NDS SURGICAL IMAGING, LLC.
 
SUBSTANTIALLY EQUIVALENT
 2
NELIS
 
SUBSTANTIALLY EQUIVALENT
 1
NEOSURGICAL LTD
 
SUBSTANTIALLY EQUIVALENT
 2
NOVADAQ TECHNOLOGIES, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
NOVATECH S.A.
 
SUBSTANTIALLY EQUIVALENT
 2
NOVATECH SA
 
SUBSTANTIALLY EQUIVALENT
 2
OLYMPUS
 
SUBSTANTIALLY EQUIVALENT
 1
OLYMPUS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
OLYMPUS MEDICAL SYSTEMS CORP.
 
SUBSTANTIALLY EQUIVALENT
 2
PROSURG, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
REGULATORY TECHNOLOGY SERVICES, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
RETRACTION LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
SANTA BARBARA IMAGING SYSTEMS
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
SONY ELECTRONICS INC.,
 
SUBSTANTIALLY EQUIVALENT
 1
SONY ELECTRONICS, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
STANDARD BARIATRICS
 
SUBSTANTIALLY EQUIVALENT
 3
STRYKER
 
SUBSTANTIALLY EQUIVALENT
 2
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 6
SYMMETRY SURGICAL
 
SUBSTANTIALLY EQUIVALENT
 1
TAIWAN SURGICAL CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
TELEFLEX MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
TELEFLEX MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
UNIMICRO MEDICAL SYSTEMS (SHENZHEN) CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 3
WICKIMED SUPPLY CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
XODUS MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Break
 1768
Detachment Of Device Component
 1015
Inflation Problem
 975
Material Fragmentation
 519
Detachment Of Device Or Device Component
 515
Packaging Problem
 370
Leak / Splash
 320
Device Packaging Compromised
 224
Adverse Event Without Identified Device Or Use Problem
 218
Difficult To Insert
 202
Material Separation
 150
Burst Container Or Vessel
141
Difficult To Remove
130
Mechanics Altered
 118
Activation, Positioning Or Separation Problem
 117
Gas Leak
 115
Failure To Fire
108
Noise, Audible
 104
Torn Material
 103
Fracture
 100
Air Leak
 91
Mechanical Problem
 83
Device Operates Differently Than Expected
 78
Material Deformation
 68
Failure To Adhere Or Bond
 61
Material Perforation
 53
No Display / Image
 51
Mechanical Jam
 50
Needle
 48
Human-Device Interface Problem
 48
Hole In Material
 44
Deflation Problem
 42
Optical Problem
 40
Bent
 39
Material Rupture
 37
Physical Resistance
 36
Material Split, Cut Or Torn
 36
Failure To Cut
 33
Balloon
 33
Thermal Decomposition Of Device
 32
Loss Of Or Failure To Bond
 30
Use Of Device Problem
 29
Misfire
27
Sparking
 27
Component Falling
 27
Failure To Form Staple
 27
Smoking
 26
Tip
 25
Device Contamination With Chemical Or Other Material
 23
Image Resolution Poor
 22
Trocar
 21
Insufficient Information
 21
Device Slipped
 20
Display Or Visual Feedback Problem
 20
Erratic Or Intermittent Display
 20
Positioning Failure
20
Retraction Problem
 20
Electrical /Electronic Property Problem
 20
Product Quality Problem
 19
Tear, Rip Or Hole In Device Packaging
 18
Melted
 18
Entrapment Of Device
 18
Component Missing
17
Failure To Advance
 17
Endoscope
 16
Sharp Edges
 16
Fluid Leak
 16
Crack
 16
Difficult To Open Or Close
 15
Seal
 14
Material Integrity Problem
 14
Cut In Material
 14
No Device Output
12
Dull, Blunt
 12
Improper Device Output
 12
Difficult Or Delayed Positioning
 12
Appropriate Term/Code Not Available
 11
Physical Resistance / Sticking
 11
Poor Quality Image
10
Peeled / Delaminated
 10
Device Or Device Fragments Location Unknown
 10
Material Puncture / Hole
 10
Fire
 10
Suture
 9
Device Difficult To Setup Or Prepare
 9
Device Dislodged Or Dislocated
 8
Structural Problem
 8
Device Operational Issue
 8
Temperature Problem
 8
Overheating Of Device
 8
False Device Output
 8
Out-Of-Box Failure
 8
Fitting Problem
 7
Device Damaged Prior To Use
7
Loose Or Intermittent Connection
 7
Defective Component
 7
Corroded
7
Jaw
 7
Cannula
 7
Connection Problem
 6
Total Device Problems 9217
Recalls
Manufacturer Recall Class Date Posted
1
Applied Medical Resources Corp
 II Jun-14-2017
2
Applied Medical Resources Corp
 II Jan-24-2014
3
Banyan Medical, LLC
 II Oct-13-2016
4
Carefusion 2200 Inc
 I Jul-22-2016
5
Cook Inc.
 II Jun-08-2017
6
Covidien LLC
 II Jun-23-2017
7
Davol, Inc., Subs. C. R. Bard, Inc.
 II Jun-02-2014
8
DeRoyal Industries Inc
 II May-21-2015
9
EXP Pharmaceutical Services Corp
 II Jul-24-2015
10
Espiner Medical Ltd
 II Nov-10-2018
11
Ethicon Endo-Surgery Inc
 II May-15-2018
12
Genicon, Inc.
 II Mar-16-2018
13
Intuitive Surgical, Inc.
 II Dec-19-2014
14
Lumenis
 II Sep-16-2015
15
Novadaq Technologies Inc.
 II Mar-02-2016
16
Pentax Medical Company
 II Jul-23-2016
17
Pentax Medical Company
 II Jun-28-2016
18
Stryker Corporation
 II Mar-02-2018
19
Stryker Endoscopy
 II Dec-12-2014
20
Teleflex Medical
 II Oct-07-2016
21
Teleflex Medical
 II Apr-02-2014
22
Teleflex Medical
 II Mar-25-2014
23
Terumo Cardiovascular Systems Corporation
 II Feb-21-2014
24
US Endoscopy Group Inc
 III Mar-08-2017
TPLC Last Update: 2019-04-02 21:06:34
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