OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
FDA 510(k) clearance K060243 · decided 2006-06-23
Clearance details
- K-number
- K060243
- Device name
- OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2006-01-31
- Decision date
- 2006-06-23
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- EOQ
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus Medical Systems Corporation
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 Single Use Guide Sheath Kits with the following product descriptions and model num recall (Z-1071-2025) | Olympus Corporation of the Americas | 2025-02-11 |