OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
FDA 510(k) clearance K000948 · decided 2000-05-12
Clearance details
- K-number
- K000948
- Device name
- OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1
- Applicant
- Keymed (Medical & Industrial Equipment), Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-23
- Decision date
- 2000-05-12
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- FEQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Southend-On-Sea, Essex, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Keymed (Medical & Industrial Equipment)
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Olympus OFP Flushing Pump irrigation tubing The Olympus OFP Flushing Pump is a peristaltic recall (Z-0806-2012) | Olympus America Inc. | 2012-01-18 |