Enema Kit

Device Code: 1746

Product Code(s): FCE

Definition: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is

Device Classification Information

• Device Type ID: 1746
• Device Name: Enema Kit
• Physical State: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is
• Technical Method: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is
• Target Area: This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.This Type Of Convenience Kit, As Listed In The Guidance Above, Is
• Regulation Description: Enema Kit.
• 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); Gastroenterology Devices Branch (GEDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 876.5210 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: FCE
• GMP Exempt: Yes
• 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: 1746
• Device: Enema Kit
• Product Code: FCE
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Enema Kit.
• CFR Regulation Number: 876.5210 [🔎]

Device Problems
Detachment Of Device Component	1
Misassembly By Users	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:58:56