Pneumoperitoneum Needle

Device Code: 1842

Product Code(s): FHO

Definition: For Establishment Of A Pneumoperitoneum In Abdomen.

Device Classification Information

• Device Type ID: 1842
• Device Name: Pneumoperitoneum Needle
• Physical State: May Include: Needle, Stylet, Housing Handle.
• Technical Method: Instrument Inserted Into Abdomen And Gasses Or Fluids Are Passed Into Needle To Inflate The Abdominal Cavity.
• Target Area: Abdominal Cavity
• 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); Renal Devices Branch (RNDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.1500 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FHO
• 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: 1842
• Device: Pneumoperitoneum Needle
• Product Code: FHO
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endoscope And Accessories.
• CFR Regulation Number: 876.1500 [🔎]

Device Problems
Detachment Of Device Component	1
Difficult Or Delayed Positioning	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 20:00:34