Definition: This Product Code Is The Class II Exempt Counterpart Of OCZ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k))
| Device Type ID | 2154 |
| Device Name | Endoscopic Grasping/cutting Instrument, Non-powered, Exempt |
| Physical State | Exemption Is Limited To Disposable, Single Use Non-powered Endoscopic Grasping/cutting Instruments. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of OCZ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| Target Area | This Product Code Is The Class II Exempt Counterpart Of OCZ, And Was Exempted, Subject To The Limitations Of Exemption, Under The Procedures Established By The 21st Century Cures Act. This Device Type Does Not Require Premarket Notification (510(k)) |
| 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 | 510(K) Exempt |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2154 |
| Device | Endoscopic Grasping/cutting Instrument, Non-powered, Exempt |
| Product Code | PTS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Difficult To Open Or Close | 8 |
Dull, Blunt | 6 |
Failure To Align | 6 |
Break | 4 |
Detachment Of Device Or Device Component | 3 |
Appropriate Term/Code Not Available | 3 |
Mechanical Problem | 2 |
Peeled / Delaminated | 1 |
Retraction Problem | 1 |
Solder Joint Fracture | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 36 |