K160501 is an FDA 510(k) clearance for the Noxilizer Surgical Ruler. This device is classified as a Tape, Measuring, Rulers And Calipers (Class I - General Controls, product code FTY).
Submitted by Noxilizer, Inc. (Baltimore, US). The FDA issued a Cleared decision on May 26, 2016, 93 days after receiving the submission on February 23, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.
| 510(k) Number | K160501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2016 |
| Decision Date | May 26, 2016 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTY — Tape, Measuring, Rulers And Calipers |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4800 |