Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
FDA 510(k) clearance K143186 · decided 2014-12-18
Clearance details
- K-number
- K143186
- Device name
- Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector
- Applicant
- Erbe USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-05
- Decision date
- 2014-12-18
- Days to decision
- 43 days
- Clearance type
- Special
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.