Sigmoidoscope And Accessories, Flexible/rigid

Device Code: 1725

Product Code(s): FAM

Definition: To Examine And Perform Procedures Within The Sigmoid (descending) Colon

Device Classification Information

• Device Type ID: 1725
• Device Name: Sigmoidoscope And Accessories, Flexible/rigid
• Physical State: Endoscope, Accessories Associated With Sigmoidoscope
• Technical Method: Instrument Guided Through Rectum Into The Large Intestine
• Target Area: Sigmoid (descending) Colon
• 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: FAM
• 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: 1725
• Device: Sigmoidoscope And Accessories, Flexible/rigid
• Product Code: FAM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscope And Accessories.
• CFR Regulation Number: 876.1500 [🔎]

Device Problems
Device Issue	2
Overheating Of Device	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Pentax Medical Company	II	Jul-23-2016
2	Pentax Medical Company	II	Jun-28-2016

TPLC Last Update: 2019-04-02 19:58:37