OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
FDA 510(k) clearance K100899 · decided 2010-09-13
Clearance details
- K-number
- K100899
- Device name
- OLYMPUS ENDOSCOPIC FLUSHING PUMP, MODEL OPF-2
- Applicant
- Keymed (Medical & Industrial Equipment), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-31
- Decision date
- 2010-09-13
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- FEQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141) recall (Z-0229-2025) | Olympus Corporation of the Americas | 2024-10-25 |
| MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection betwe recall (Z-0113-2016) | Olympus Corporation of the Americas | 2015-10-08 |
| Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove bl recall (Z-0329-2014) | Olympus America Inc. | 2013-11-15 |