Apparatus, Pneumoperitoneum, Automatic

Device Code: 5453

Product Code(s): FDP

Device Classification Information

• Device Type ID: 5453
• Device Name: Apparatus, Pneumoperitoneum, Automatic
• Regulation Description: Endoscope And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General & Plastic Surgery
• 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: FDP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons 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: 5453
• Device: Apparatus, Pneumoperitoneum, Automatic
• Product Code: FDP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscope And Accessories.
• CFR Regulation Number: 876.1500 [🔎]

Device Problems
Flaked	1
Device Disinfection Or Sterilization Issue	1
Material Integrity Problem	1
Device Operates Differently Than Expected	1
Retraction Problem	1
Appropriate Term/Code Not Available	1
Total Device Problems	6

TPLC Last Update: 2019-04-02 21:06:29