Submission Details
| 510(k) Number | K172800 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Portex? Lancet Point Spinal Needles with NRFit? connectors, Portex? Pencil Point Spinal Needles with NRFit? connectors
Jun 2018
Decision
269d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 868.5150.
Device Classification
| Product Code | MIA — Needle, Spinal, Short Term |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5150 |
Manufacturer
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