K172800 is an FDA 510(k) clearance for the Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors. This device is classified as a Needle, Spinal, Short Term (Class II - Special Controls, product code MIA).
Submitted by Smiths Medical Asd, Inc. (Plymouth, US). The FDA issued a Cleared decision on June 14, 2018, 269 days after receiving the submission on September 18, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5150.
| 510(k) Number | K172800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2017 |
| Decision Date | June 14, 2018 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MIA — Needle, Spinal, Short Term |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5150 |