Arthroscope

Device Code: 4463

Product Code(s): HRX

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 ID4463
Device NameArthroscope
Regulation DescriptionArthroscope.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Restorative And Repair Devices Branch (RRDB)
Submission Type510(k)
CFR Regulation Number888.1100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeHRX
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 ID4463
DeviceArthroscope
Product CodeHRX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionArthroscope.
CFR Regulation Number888.1100 [🔎]
Premarket Reviews
ManufacturerDecision
BAYLIS MEDICAL COMPANY INC.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOPSYBELL S.R.L.
 
SUBSTANTIALLY EQUIVALENT
 1
BIOVISION TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
 2
CAREFUSION
 
SUBSTANTIALLY EQUIVALENT
 2
CONMED
 
SUBSTANTIALLY EQUIVALENT
 1
CONMED CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
GALLINI MEDICAL DEVICES, SRL
 
SUBSTANTIALLY EQUIVALENT
 1
IMEDICOM CO., LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
INTEGRATED ENDOSCOPY, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDOS INTERNATIONAL SARL
 
SUBSTANTIALLY EQUIVALENT
 2
MEDTRONIC INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MEDTRONIC, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
MICROAIRE SURGICAL INSTRUMENTS, LLC
 
SUBSTANTIALLY EQUIVALENT
 1
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED
 
SUBSTANTIALLY EQUIVALENT
 1
OLYMPUS
 
SUBSTANTIALLY EQUIVALENT
 1
OLYMPUS CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 1
ORTHOPEDIC SCIENCES,
 
SUBSTANTIALLY EQUIVALENT
 1
PROSURG, INC
 
SUBSTANTIALLY EQUIVALENT
 1
PROVIDENCE MEDICAL TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
 2
RENOVO, INC
 
SUBSTANTIALLY EQUIVALENT
 1
RZ MEDIZINTECHNIK GMBH
 
SUBSTANTIALLY EQUIVALENT
 1
SCHOLLY FIBEROPTIC
 
SUBSTANTIALLY EQUIVALENT
 1
SMITH & NEPHEW, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER
 
SUBSTANTIALLY EQUIVALENT
 1
STRYKER CORP.
 
SUBSTANTIALLY EQUIVALENT
 5
STRYKER CORPORATION
 
SUBSTANTIALLY EQUIVALENT
 4
TRICE MEDICAL
 
SUBSTANTIALLY EQUIVALENT
 1
TRICE MEDICAL, INC.
 
SUBSTANTIALLY EQUIVALENT
 1
VISIONSENSE LTD.
 
SUBSTANTIALLY EQUIVALENT
 1
W.O.M. WORLD OF MEDICINE AG
 
SUBSTANTIALLY EQUIVALENT
 1
Device Problems
Material Rupture
 230
Overfill
 187
Electrical Shorting
 161
Break
 159
Suction Failure
 120
Increase In Pressure
 107
Metal Shedding Debris
 96
Leak / Splash
 93
Adverse Event Without Identified Device Or Use Problem
 74
Suction Problem
 72
Overheating Of Device
 70
Detachment Of Device Or Device Component
 68
Material Fragmentation
 68
Disassembly
 67
Fluid Leak
 66
Pressure Problem
 60
Intermittent Loss Of Power
 53
Material Disintegration
 51
Positioning Problem
 47
Excess Flow Or Over-Infusion
 45
Device Operates Differently Than Expected
 44
Intermittent Continuity
43
Device Remains Activated
 40
Mechanical Jam
 38
Insufficient Information
 38
Poor Quality Image
37
Failure To Power Up
 36
Intermittent Energy Output
35
Filling Problem
 34
Peeled / Delaminated
 30
Device Stops Intermittently
 28
Mechanical Problem
 24
Unintended System Motion
 16
Fail-Safe Problem
 16
Defective Component
 15
Unintended Power Up
14
Detachment Of Device Component
 13
Device Contamination With Chemical Or Other Material
 13
Appropriate Term/Code Not Available
 12
Loss Of Or Failure To Bond
 11
Unknown (for Use When The Device Problem Is Not Known)
 11
Unintended Movement
 11
Loose Or Intermittent Connection
 10
Fracture
 10
Inflation Problem
 8
Migration Or Expulsion Of Device
8
Device Operational Issue
 8
Device Inoperable
 8
Device Displays Incorrect Message
8
Incomplete Or Inadequate Connection
 8
Device-Device Incompatibility
 7
Noise, Audible
 7
Deflation Problem
 7
Electrical /Electronic Property Problem
 6
Failure To Advance
 6
Bent
 5
Electrical Power Problem
 5
Self-Activation Or Keying
5
Component Missing
5
Smoking
 5
Improper Flow Or Infusion
 5
Failure To Disconnect
 5
Physical Resistance / Sticking
 5
Sticking
 5
Component Incompatible
 5
Image Display Error / Artifact
 4
Short Fill
 4
Incomplete Coaptation
 4
Use Of Device Problem
 4
Burst Container Or Vessel
4
Material Integrity Problem
 3
Unstable
 3
Vibration
 3
Corroded
3
No Display / Image
 3
Unintended Ejection
3
Insufficient Flow Or Under Infusion
 3
Decrease In Suction
 3
Misfocusing
 3
Increased Pump Speed
 3
Partial Blockage
 3
Material Deformation
 3
Unexpected Shutdown
 3
Locking Mechanism
 2
Loss Of Power
 2
Material Separation
 2
Device Issue
 2
Device Slipped
 2
Failure To Run On AC/DC
 2
Thermal Decomposition Of Device
 2
Erratic Or Intermittent Display
 2
Fogging
 2
Lenses
 2
Material Puncture / Hole
 2
Activation Problem
2
Activation, Positioning Or Separation Problem
 2
Tip
 2
Output Above Specifications
 2
Connection Problem
 2
Balloon
 2
Total Device Problems 2697
Recalls
Manufacturer Recall Class Date Posted
1
Biomet, Inc.
 II May-26-2016
2
Customed, Inc
 II Sep-03-2015
3
DePuy Mitek, Inc., A Johnson & Johnson Co.
 II Jan-15-2016
4
Instratek, Incorporated
 II Dec-22-2015
5
Medical Vision Ab
 II Aug-30-2016
6
MicroAire Surgical Instruments, LLC
 II May-25-2018
7
Myelotec, Inc.
 II Jul-28-2017
8
Richard Wolf GmbH
 II Aug-22-2018
9
Richard Wolf Medical Instruments Corp.
 II Feb-09-2016
10
Stryker Endoscopy
 II Jun-25-2014
11
Stryker Instruments Div. Of Stryker Corporation
 II Mar-28-2018
12
Stryker Sustainability Solutions
 II Mar-05-2019
13
The Anspach Effort, Inc.
 II Jun-25-2014
TPLC Last Update: 2019-04-02 20:49:46
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