Cystourethroscope

Device Code: 1738

Product Code(s): FBO

Device Classification Information

• Device Type ID: 1738
• Device Name: Cystourethroscope
• Regulation Description: Endoscope And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Urology And Lithotripsy Devices Branch (ULDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.1500 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FBO
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 6-389 IEC 60601-2-2 Edition 6.0 2017-03
  Medical Electrical Equipment - Part 2-2: Particular Requirements For The Basic Safety And Essential Performance Of High Frequency Surgical Equipment And High Frequency Surgical Accessories
• 9-39 ISO 8600-5 First Edition 2005-03-15
  Optics And Photonics - Medical Endoscopes And Endotherapy Devices - Part 5: Determination Of Optical Resolution Of Rigid Endoscopes With Optics
• 9-40 ISO 8600-6 First Edition 2005-03-15
  Optics And Photonics - Medical Endoscopes And Endotherapy Devices - Part 6: Vocabulary
• 9-84 ISO 8600-3 First Edition 1997-07-01 (Amendment 1 2003-12-01
  Optics And Optical Instruments - Medical Endoscopes And Endoscopic Accessories - Part 3: Determination Of Field Of View And Direction Of View Of Endoscopes With Optics [Including: Amendment 1 (2003)]
• 9-94 ISO 8600-4 Second Edition 2014-03-15
  Endoscopes - Medical Endoscopes And Certain Accessories - Part 4: Determination Of Maximum Width Of Insertion Portion
• 9-110 ISO 8600-1 Fourth Edition 2015-10-15
  Endoscopes - Medical Endoscopes And Endotherapy Devices -- Part 1: General Requirements

Total Product Life Cycle

• Device Type ID: 1738
• Device: Cystourethroscope
• Product Code: FBO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscope And Accessories.
• CFR Regulation Number: 876.1500 [🔎]

Premarket Reviews
Manufacturer	Decision
KARL STORZ GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
KARL STORZ SE & CO KG
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Material Separation	13
Contamination / Decontamination Problem	9
Maintenance Does Not Comply To Manufacturers Recommendations	6
Sparking	6
Break	4
Detachment Of Device Component	3
Wire(s), Breakage Of	2
Flare Or Flash	2
Tip	2
No Display / Image	1
Smoking	1
Adverse Event Without Identified Device Or Use Problem	1
Bent	1
Material Disintegration	1
Device Issue	1
Material Fragmentation	1
Arcing	1
Electrical Shorting	1
Charred	1
Flaked	1
Total Device Problems	58

TPLC Last Update: 2019-04-02 19:58:50