Submission Details
| 510(k) Number | K173110 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2017 |
| Decision Date | May 18, 2018 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
GRAFTSITE
May 2018
Decision
231d
Days
Class 2
Risk
About This 510(k) Submission
K173110 is an FDA 510(k) clearance for the GRAFTSITE, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by Summit Medical , Ltd. (Bourton On The Water, GB). The FDA issued a Cleared decision on May 18, 2018, 231 days after receiving the submission on September 29, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.
Device Classification
| Product Code | BSP — Needle, Conduction, Anesthetic (w/wo Introducer) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5150 |
Manufacturer
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