MYELOTEC MYELOSCOPE
FDA 510(k) clearance K960194 · decided 1996-09-04
Clearance details
- K-number
- K960194
- Device name
- MYELOTEC MYELOSCOPE
- Applicant
- Myelotec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-16
- Decision date
- 1996-09-04
- Days to decision
- 232 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Great Neck,, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Myelotec
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 |
|---|---|---|
| Myelotec Steerable Video Guided Catheter, 2.7mm, label insert for LB0013-1, LB0013-2, and recall (Z-0586-2008) | Myelotec, Inc. | 2008-04-10 |