K020480 is an FDA 510(k) clearance for the RBM. This device is classified as a Retention Device, Suture (Class I - General Controls, product code KGS).
Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on March 12, 2002, 27 days after receiving the submission on February 13, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.
| 510(k) Number | K020480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2002 |
| Decision Date | March 12, 2002 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGS — Retention Device, Suture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4930 |