Definition: To Supply Sterile Water, Other Solutions And/or Suction To Endoscopes During Endoscopic Procedures.
| Device Type ID | 2065 |
| Device Name | Endoscopic Irrigation/suction System |
| Physical State | May Include: Pump, Motor, Tubing, Controller, Air Switch, Power Supply, Transducer, Digital Display, Suction Attachment, Bottle Cap |
| Technical Method | Connects To Tubing From Pump And Goes Down Working Channel Of Endoscope |
| Target Area | Endoscope |
| 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) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2065 |
| Device | Endoscopic Irrigation/suction System |
| Product Code | OCX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
C2 THERAPEUTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ERBE ELEKTROMEDIZIN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ERBE USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDIVATORS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVATORS REPROCESSING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILLIPS D. HAMILTON II | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROMEPLA SAM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMARTDATA SUZHOU CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Leak / Splash | 8 |
Material Fragmentation | 7 |
Fluid Leak | 4 |
Detachment Of Device Or Device Component | 3 |
Device Issue | 3 |
Detachment Of Device Component | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Misassembled | 1 |
Material Puncture / Hole | 1 |
Retraction Problem | 1 |
Suction Problem | 1 |
Device Operational Issue | 1 |
Device Contamination With Chemical Or Other Material | 1 |
| Total Device Problems | 35 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp. | II | Jan-26-2015 |
| 2 | US Endoscopy Group Inc | II | Jul-01-2015 |