Snare, Non-electrical

Device Code: 1832

Product Code(s): FGX

Device Classification Information

• Device Type ID: 1832
• Device Name: Snare, Non-electrical
• Regulation Description: Manual Gastroenterology-urology Surgical Instrument 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) Exempt
• CFR Regulation Number: 876.4730 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FGX
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

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: 1832
• Device: Snare, Non-electrical
• Product Code: FGX
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Gastroenterology-urology Surgical Instrument And Accessories.
• CFR Regulation Number: 876.4730 [🔎]

Device Problems
Defective Device	6
Retraction Problem	6
Break	5
Appropriate Term/Code Not Available	1
Total Device Problems	18

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jan-11-2014

TPLC Last Update: 2019-04-02 20:00:24