OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
FDA 510(k) clearance K123421 · decided 2013-04-29
Clearance details
- K-number
- K123421
- Device name
- OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-06
- Decision date
- 2013-04-29
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- NEZ
- Device class
- 2
- Regulation number
- 876.1300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.