Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS
K143159 is the FDA 510(k) clearance record for Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS, a class II device, cleared for Spineguard S.A. on under FDA product code PDQ (Neurosurgical Nerve Locator). FDA's definition for product code PDQ reads: "To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery". FDA records list 7 510(k) clearances for Spineguard S.A., from to . As of , FDA records show no recalls naming K143159.
Clearance record
- Decision date
- Received
- (81 days to decision)
- Product code
- PDQ Neurosurgical Nerve Locator
- Regulation
- 21 CFR 874.1820
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Applicant
- Spineguard S.A. 5-7 Rue De L’Amiral Courbet, Saint Mande, FR
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code PDQ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 1 |
| May 2026 | 0 |
| June 2026 | 1 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 0 |
| October 2026 | 0 |
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