Endoscope Holder

Device Code: 2063

Product Code(s): OCV

Definition: To Hold Endoscope In A Desired Position During Procedures.

Device Classification Information

• Device Type ID: 2063
• Device Name: Endoscope Holder
• Physical State: Holder
• Technical Method: Endoscope Placed Or Mounted Onto Holder
• Target Area: Endoscope
• 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: OCV
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 9-53 ASTM F1992 -99 (Reapproved 2007)
  Standard Practice For Reprocessing Of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used With Flexible Endoscopes

Total Product Life Cycle

• Device Type ID: 2063
• Device: Endoscope Holder
• Product Code: OCV
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscope And Accessories.
• CFR Regulation Number: 876.1500 [🔎]

TPLC Last Update: 2019-04-02 20:05:16