XENX
FDA 510(k) clearance K113692 · decided 2012-08-09
Clearance details
- K-number
- K113692
- Device name
- XENX
- Applicant
- Xenolith Medical
- Decision
- Substantially Equivalent
- Date received
- 2011-12-15
- Decision date
- 2012-08-09
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- OCY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kityat-Gat, IL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Xenolith Medical
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
No recalls on record reference this clearance.