Definition: The "Endoscope And Accessories, Reprocessed" Is Intended To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals. This Device Is Indicated For Reuse/reprocessing.
| Device Type ID | 2020 |
| Device Name | Laparoscope, General & Plastic Surgery, Reprocessed |
| 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) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NLM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2020 |
| Device | Laparoscope, General & Plastic Surgery, Reprocessed |
| Product Code | NLM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RENOVO, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STERILMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERILMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 36 |
Break | 35 |
Device Contamination With Chemical Or Other Material | 17 |
Material Integrity Problem | 6 |
Improper Device Output | 2 |
Fracture | 2 |
False Device Output | 2 |
Material Fragmentation | 2 |
Protective Measures Problem | 2 |
Insufficient Information | 2 |
Cannula, Outer | 1 |
Material Separation | 1 |
Device Contaminated During Manufacture Or Shipping | 1 |
Detachment Of Device Component | 1 |
Device Operates Differently Than Expected | 1 |
Failure To Cycle | 1 |
Material Frayed | 1 |
Delivered As Unsterile Product | 1 |
| Total Device Problems | 114 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | CooperSurgical, Inc. | II | May-19-2015 |
| 2 | Stryker Sustainability Solutions | II | Nov-27-2018 |
| 3 | Stryker Sustainability Solutions | II | Dec-14-2016 |
| 4 | Stryker Sustainability Solutions | II | Aug-27-2015 |
| 5 | Stryker Sustainability Solutions | II | Jun-25-2015 |