X-Guide Surgical Navigation System
FDA 510(k) clearance K232148 · decided 2024-02-21
Clearance details
- K-number
- K232148
- Device name
- X-Guide Surgical Navigation System
- Applicant
- X-Nav Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-07-19
- Decision date
- 2024-02-21
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- QRY
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lansdale, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch X-Nav Technologies
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.
| Record | Firm | Date |
|---|---|---|
| Yomi Robotic System (K222750) | Neocis, Inc. | 2022-12-08 |
| Yomi Robotic System (K222049) | Neocis, Inc. | 2022-11-04 |
| X-Guide® Surgical Navigation System (K211701) | X-Nav Technologies, LLC | 2022-02-01 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| X-Guide Handpiece Adaptor Sleeve 1, Model P010701 recall (Z-1392-2024) | X-NAV Technologies, LLC | 2024-03-29 |
| X-Guide Handpiece Adaptor Sleeve 3, Model P010727 recall (Z-1393-2024) | X-NAV Technologies, LLC | 2024-03-29 |