Retractor, Non-self-retaining

Device Code: 1828

Product Code(s): FGN

Device Classification Information

• Device Type ID: 1828
• Device Name: Retractor, Non-self-retaining
• 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: FGN
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1828
• Device: Retractor, Non-self-retaining
• Product Code: FGN
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Manual Gastroenterology-urology Surgical Instrument And Accessories.
• CFR Regulation Number: 876.4730 [🔎]

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