HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
FDA 510(k) clearance K080603 · decided 2008-08-05
Clearance details
- K-number
- K080603
- Device name
- HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
- Applicant
- Te ME NA Sas
- Decision
- Substantially Equivalent
- Date received
- 2008-03-03
- Decision date
- 2008-08-05
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Appollo Beach, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Te ME NA Sas
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 |
|---|---|---|
| Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item numbe recall (Z-1608-2014) | RM Temena GmbH | 2014-05-12 |
| Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item recall (Z-1609-2014) | RM Temena GmbH | 2014-05-12 |