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 Type ID | 1767 |
| Device Name | Laparoscopy 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 | 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | Enforcement Discretion |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FDE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1767 |
| Device | Laparoscopy Kit |
| Product Code | FDE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Material Integrity Problem | 5 |
Flaked | 3 |
Break | 1 |
Material Fragmentation | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Customed, Inc | II | Sep-03-2015 |
| 2 | Customed, Inc | I | Dec-16-2014 |
| 3 | Customed, Inc | I | Aug-29-2014 |